FDA Warning Letters, 483s and Recalls: March 2024
Warning letters
A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.
| Date | Company | Issuing office | Subject |
|---|---|---|---|
| Mar 29, 2024 | Central Admixture Pharmacy Services, Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Drug Products/Adulterated |
| Mar 29, 2024 | Coombe Castle International Ltd. | Center for Food Safety and Applied Nutrition (CFSAN) | Low Acid Canned Food Regulation/Adulterated |
| Mar 29, 2024 | Kitchen Garden Foods, LTD | Center for Food Safety and Applied Nutrition | Acidified Foods/Emergency Permit Control/Adulterated |
| Mar 29, 2024 | Thuan Thien Producing Trading Limited Company | Center for Food Safety and Applied Nutrition | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Mar 28, 2024 | Kilitch Healthcare India Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceutical/Adulterated |
| Mar 27, 2024 | Bodywell Natural Skin Care Inc. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Mar 27, 2024 | Vintage Chemical Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 25, 2024 | Central Admixture Pharmacy Services, Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Drug Products/Adulterated |
| Mar 25, 2024 | Dermal Source, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Mar 25, 2024 | Indelicare DBA INKEEZE | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Mar 25, 2024 | Juquilita Mexican Imports LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Mar 25, 2024 | SeeNext Venture, Ltd. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Mar 25, 2024 | Sky Bank Media, LLC Dba Painless Tattoo Cream Co. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Mar 25, 2024 | Tattoo Numbing Cream Co. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Mar 25, 2024 | TKTX Company | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Mar 22, 2024 | Antaria Pty. Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Mar 21, 2024 | Agena Bioscience, Inc. | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Mar 21, 2024 | Augustine Temperature Management, LLC | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded |
| Mar 21, 2024 | Betone S.A. De C.V. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 21, 2024 | Bret R. Rutherford, M.D. | Center for Drug Evaluation and Research | CDER | Clinical Investigator (Sponsor) |
| Mar 21, 2024 | Jolca, S.A. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated |
| Mar 21, 2024 | New York State Psychiatric Institute IRB | Center for Drug Evaluation and Research | CDER | Institutional Review Board (IRB) |
| Mar 21, 2024 | St. Louis Calco, LLC | Division of Human and Animal Food Operations West II | Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated |
| Mar 19, 2024 | Ammonia Sport Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Mar 19, 2024 | JX Restaurants, Inc. | Division of Human and Animal Food Operations West II | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
| Mar 18, 2024 | Deqing Jiarou Daily Chemical Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 18, 2024 | Jiangsu Shenli Medical Production Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Mar 18, 2024 | Medline Industries, LP | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Mar 18, 2024 | Sol-Millennium Medical, Inc. | Division of Medical Device and Radiological Health Operations Central | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Mar 15, 2024 | Beckman Coulter Inc. | Division of Medical Device and Radiological Health Operations Central | CGMP/QSR/Medical Devices/Adulterated |
| Mar 14, 2024 | F1 Foods Inc. D/B/A Flavor First Foods Inc. | Division of Human and Animal Food Operations East I | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Mar 13, 2024 | Master Paints & Chemicals Corp. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 13, 2024 | Skull Smash LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Mar 12, 2024 | Furst-McNess Company | Division of Human and Animal Food Operations West I | CGMP/Medicated Feeds/Adulterated |
| Mar 8, 2024 | Spirochaete Research Labs, LLC Aka Scitus Laboratory Products | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| Mar 6, 2024 | Procesadora Vikingo C.A. | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Mar 6, 2024 | Sen Up Huat Seafood Trading Sdn Bhd | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Mar 4, 2024 | Living Tree Community Foods, Inc. | Division of Human and Animal Food Operations West V | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Mar 1, 2024 | Boehringer Ingelheim Animal Health USA | Center for Veterinary Medicine | False & Misleading Claims/Misbranded |
| Mar 1, 2024 | Carbon Fire, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Dietary Supplement/Adulterated |
| Mar 1, 2024 | La Sucursal Produce Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
OAI inspections
OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.
| Date | Facility | Product type | Country |
|---|---|---|---|
| Mar 30, 2024 | MMC HEALTHCARE LTD. | Drugs | India |
| Mar 29, 2024 | Abbott Laboratories Inc. | Food/Cosmetics | United States |
| Mar 29, 2024 | Jiangsu Shenli Medical Production Co., Ltd. | Devices | China |
| Mar 29, 2024 | Norbrook Laboratories Limited | Veterinary | United Kingdom |
| Mar 29, 2024 | Outin Futures Corp | Drugs | Korea (the Republic of) |
| Mar 28, 2024 | Hookah Imports Inc: | Tobacco | United States |
| Mar 28, 2024 | Juicer Connections, Inc. | Food/Cosmetics | United States |
| Mar 27, 2024 | PACIFIC EXCHANGE DISTRIBUTORS | Food/Cosmetics | United States |
| Mar 27, 2024 | Zydus Lifesciences Limited | Drugs | India |
| Mar 26, 2024 | Ice Cream House LLC | Food/Cosmetics | United States |
| Mar 26, 2024 | Jjh Trading Inc | Food/Cosmetics | United States |
| Mar 26, 2024 | La Parcela Produce LLC | Food/Cosmetics | United States |
| Mar 23, 2024 | Jiangsu Caina Medical Co., Ltd | Devices | China |
| Mar 22, 2024 | Amor Nino Foods Inc | Food/Cosmetics | United States |
| Mar 22, 2024 | Big Vegetarian Supply Inc. | Food/Cosmetics | United States |
| Mar 22, 2024 | LCC Ltd. | Drugs | Korea (the Republic of) |
| Mar 22, 2024 | Tianjin Choice Medical Devices Co., Ltd. | Devices | China |
| Mar 22, 2024 | Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. | Drugs | China |
| Mar 21, 2024 | KP Pharmaceutical Technology | Drugs | United States |
| Mar 21, 2024 | Osmosis, LLC | Food/Cosmetics | United States |
| Mar 21, 2024 | PetDine, LLC. | Veterinary | United States |
| Mar 20, 2024 | AMCO International Manufacturing & Design, Inc. | Devices | United States |
| Mar 20, 2024 | Homeocare Laboratories Inc. | Drugs | United States |
| Mar 20, 2024 | Shantaba LLC | Food/Cosmetics | United States |
| Mar 19, 2024 | Actavis Laboratories UT, Inc. | Drugs | United States |
| Mar 19, 2024 | G & FIRE, Inc | Tobacco | United States |
| Mar 18, 2024 | LA Vapor Inc | Tobacco | United States |
| Mar 15, 2024 | Belleview 402 LLC | Drugs | United States |
| Mar 15, 2024 | Intercos Europe S.P.A | Drugs | Italy |
| Mar 15, 2024 | Max Chemical Inc | Drugs | United States |
| Mar 15, 2024 | Orean Personal Care Ltd | Drugs | United Kingdom |
| Mar 15, 2024 | Sunrise International Group | Food/Cosmetics | United States |
| Mar 15, 2024 | Vitti Labs, LLC | Biologics | United States |
| Mar 14, 2024 | Associated Fruit Processors (Pty) Ltd. | Food/Cosmetics | South Africa |
| Mar 14, 2024 | Corporacion Avicola Morovis, Inc. | Food/Cosmetics | United States |
| Mar 14, 2024 | J&R Produce, Inc. | Food/Cosmetics | United States |
| Mar 14, 2024 | Kenex (Electro-Medical) Ltd. | Devices | United Kingdom |
| Mar 14, 2024 | Western Cape Fruit Processors (Pty) Ltd | Food/Cosmetics | South Africa |
| Mar 13, 2024 | Fuyang Fuchunjiang Canned Food Co.,Ltd. | Food/Cosmetics | China |
| Mar 13, 2024 | RMG Produce, LLC. | Food/Cosmetics | United States |
| Mar 12, 2024 | P & L Bean Sprout Farm | Food/Cosmetics | United States |
| Mar 12, 2024 | Smoke Shop Direct Dist, Inc. | Tobacco | United States |
| Mar 11, 2024 | J. Robert Flamini, MD | Drugs | United States |
| Mar 11, 2024 | LA SERRANITA IMPORT AND EXPORT LLC | Food/Cosmetics | United States |
| Mar 8, 2024 | Agustson A/S | Food/Cosmetics | Denmark |
| Mar 8, 2024 | Frontier Biologics LLC | Biologics | United States |
| Mar 8, 2024 | JC FINEST PRODUCE INC | Food/Cosmetics | United States |
| Mar 8, 2024 | Khandige Organic Health Products Pvt Ltd | Food/Cosmetics | India |
| Mar 8, 2024 | Sure-Biochem Laboratories, LLC | Drugs | United States |
| Mar 7, 2024 | Globus Medical, Inc. | Devices | United States |
| Mar 7, 2024 | Janaki (NMI) Nadarajah DPM | Drugs | United States |
| Mar 7, 2024 | Philips Medizin Systeme Boeblingen Gmbh | Devices | Germany |
| Mar 7, 2024 | Ram Goods LLC | Tobacco | United States |
| Mar 7, 2024 | WANABANA USA LLC | Food/Cosmetics | United States |
| Mar 6, 2024 | Caribbean Produce Exchange, LLC | Food/Cosmetics | United States |
| Mar 6, 2024 | Charanga Catering, LLC | Food/Cosmetics | United States |
| Mar 6, 2024 | D&A Distribution, LLC D/B/A Strictly E-Cig | Tobacco | United States |
| Mar 6, 2024 | Frenchman Valley Farmers Cooperative, Inc. | Veterinary | United States |
| Mar 6, 2024 | NRS Enterprises, Inc. | Food/Cosmetics | United States |
| Mar 6, 2024 | Purcell International | Food/Cosmetics | United States |
| Mar 5, 2024 | Agustson A/S | Food/Cosmetics | Denmark |
| Mar 5, 2024 | K2 Distro LLC | Tobacco | United States |
| Mar 4, 2024 | Amin Trading Agency LLC | Food/Cosmetics | United States |
| Mar 4, 2024 | HH FRESH TRADING CORP | Food/Cosmetics | United States |
| Mar 1, 2024 | IntegraDose Compounding Services LLC | Drugs | United States |
| Mar 1, 2024 | Kaylaan LLC | Drugs | United States |
| Mar 1, 2024 | Optikem International, Inc. | Devices | United States |
| Mar 1, 2024 | Wa Heng Dou-Fu And Soy Sauce Corporation | Food/Cosmetics | United States |
Most-cited Form 483 sections
The CFR sections FDA investigators cited most often in inspections that ended this month.
| CFR section | Observation | Citations |
|---|---|---|
| 21 CFR 1.502(a) | Develop FSVP | 54 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 37 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 29 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 23 |
| 21 CFR 117.35(c) | Pest control | 20 |
| 21 CFR 117.40 | Equipment and utensils - Design and maintenance | 20 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 20 |
| 21 CFR 211.192 | Written record of investigation incomplete | 19 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 19 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 18 |
Class I recalls
Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.
| Date | Firm | Product type | Reason |
|---|---|---|---|
| Mar 29, 2024 | THE HAIN CELESTIAL GROUP INC | Food | Undeclared milk |
| Mar 29, 2024 | Tropicale Foods, Inc. | Food | Salmonella contamination |
| Mar 28, 2024 | AvKARE | Drugs | Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. |
| Mar 28, 2024 | Geissler's Supermarket | Food | Undeclared allergens (egg) |
| Mar 28, 2024 | Geissler's Supermarket | Food | undeclared allergens (wheat) |
| Mar 28, 2024 | Geissler's Supermarket | Food | undeclared allergens (egg) |
| Mar 28, 2024 | Geissler's Supermarket | Food | undeclared allergens (wheat) |
| Mar 28, 2024 | Geissler's Supermarket | Food | undeclared allergens (egg) |
| Mar 26, 2024 | Medtronic Navigation, Inc. | Devices | Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop… |
| Mar 26, 2024 | Philips Respironics, Inc. | Devices | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation… |
| Mar 26, 2024 | Philips Respironics, Inc. | Devices | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation… |
| Mar 26, 2024 | Philips Respironics, Inc. | Devices | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation… |
| Mar 26, 2024 | Robeson Enterprises | Food | During an inspection by NCDA, the firm was notified that the label fails to declare the allergen egg as an ingredient or in the allergen… |
| Mar 26, 2024 | Robeson Enterprises | Food | During an inspection by NCDA, the firm was notified that the product contains undeclared milk and eggs. The label fails to list any sub… |
| Mar 26, 2024 | Robeson Enterprises | Food | The firm was notified that the label did not list any sub ingredients. The product contains pimento cheese which is made with mayonnaise… |
| Mar 26, 2024 | Robeson Enterprises | Food | During an inspection by NCDA, the firm was notified that the label fails to declare the allergen soy as an ingredient. The firm was also… |
| Mar 25, 2024 | SonarMed Inc | Devices | Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor. |
| Mar 23, 2024 | Aruba Aloe Balm N.V. | Drugs | Chemical Contamination: Product manufactured with ethanol API that contains methanol |
| Mar 23, 2024 | Aruba Aloe Balm N.V. | Drugs | Chemical Contamination: Product manufactured with ethanol API that contains methanol |
| Mar 21, 2024 | Amneal Pharmaceuticals Of New York, LLC | Drugs | Superpotent Drug: Due to overfilling of drug powder |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | Boston Scientific Corporation | Devices | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is… |
| Mar 21, 2024 | SonarMed Inc | Devices | The failure to detect the partial obstruction in a 2.5mm sensor. |
| Mar 21, 2024 | SonarMed Inc | Devices | The failure to detect the partial obstruction in a 2.5mm sensor. |
| Mar 21, 2024 | SonarMed Inc | Devices | The failure to detect the partial obstruction in a 2.5mm sensor. |
| Mar 20, 2024 | Belgian Yummies | Food | Undeclared Allergen: milk, eggs, wheat, peanuts, and tree nuts. |
| Mar 20, 2024 | Belgian Yummies | Food | Undeclared Allergen: milk, eggs, soy, wheat, peanuts, and tree nuts. |
| Mar 20, 2024 | Belgian Yummies | Food | Undeclared Allergen: milk, eggs, wheat, peanuts, and tree nuts. |
| Mar 20, 2024 | Belgian Yummies | Food | Undeclared Allergen: milk, eggs, soy, wheat, peanuts, and tree nuts. |
| Mar 20, 2024 | Belgian Yummies | Food | Undeclared Allergen: milk and wheat. |
| Mar 20, 2024 | Belgian Yummies | Food | Undeclared Allergen: milk, eggs, wheat, peanuts, and tree nuts. |
| Mar 20, 2024 | Belgian Yummies | Food | Undeclared Allergen: milk,eggs, wheat, peanuts, and tree nuts. |
| Mar 20, 2024 | Draeger Medical, Inc. | Devices | Unexpected shutdown while operating on battery power. |
| Mar 19, 2024 | Philips Respironics, Inc. | Devices | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| Mar 19, 2024 | Philips Respironics, Inc. | Devices | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| Mar 19, 2024 | Philips Respironics, Inc. | Devices | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| Mar 19, 2024 | Philips Respironics, Inc. | Devices | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| Mar 19, 2024 | Philips Respironics, Inc. | Devices | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| Mar 19, 2024 | Philips Respironics, Inc. | Devices | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| Mar 19, 2024 | Philips Respironics, Inc. | Devices | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| Mar 19, 2024 | Pyramids Wholesale Inc. | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. |
| Mar 19, 2024 | Pyramids Wholesale Inc. | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. |
| Mar 19, 2024 | Pyramids Wholesale Inc. | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. |
| Mar 19, 2024 | Pyramids Wholesale Inc. | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. |
| Mar 19, 2024 | Pyramids Wholesale Inc. | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. |
| Mar 19, 2024 | Pyramids Wholesale Inc. | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. |
| Mar 19, 2024 | Pyramids Wholesale Inc. | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. |
| Mar 19, 2024 | Pyramids Wholesale Inc. | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. |
| Mar 19, 2024 | Pyramids Wholesale Inc. | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. |
| Mar 19, 2024 | Pyramids Wholesale Inc. | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. |
| Mar 19, 2024 | Pyramids Wholesale Inc. | Drugs | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. |
| Mar 18, 2024 | Naturz Organics USA LLC | Food | Possible salmonella contamination |
| Mar 15, 2024 | Elekta Instrument AB | Devices | Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the… |
| Mar 15, 2024 | Wenders LLC | Food | Potential contamination with Salmonella. |
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