FDA Warning Letters, 483s and Recalls: August 2025
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 |
|---|---|---|---|
| Aug 27, 2025 | Amneal Pharmaceuticals, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 25, 2025 | Green Vitality Dba Gr33N | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| Aug 25, 2025 | Homeopathic Educational Services Dba Homeopathic Family Medicine | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| Aug 25, 2025 | Life Enthusiast Co-Op | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| Aug 25, 2025 | Mel Honey US | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| Aug 25, 2025 | My Holistic Honey C/O Shenzhen Qanhai Wanb Express Supply Chain Co., LTD | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| Aug 25, 2025 | Supply Center USA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| Aug 25, 2025 | Tan Nam Corporation | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Aug 25, 2025 | The Richline Group, Inc. | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Aug 25, 2025 | Trew Balance | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| Aug 22, 2025 | Wisconsin Pharmacal Company, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 21, 2025 | Carolina Seafood Inc. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated |
| Aug 21, 2025 | Nestor Reyes Farm & Associates | Human Foods Program | PHS Act/Shell Egg Regulation/Adulterated |
| Aug 21, 2025 | SeniorLife Technologies, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Aug 20, 2025 | Chromatography Institute Of America Dba Compounder’S International Analytical Laboratory | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/API/Adulterated |
| Aug 20, 2025 | Hikal Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Aug 19, 2025 | Miach Orthopaedics | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Aug 15, 2025 | Innate Healthcare Institute | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Aug 15, 2025 | Meds For Vets, LLC | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated/Misbranded |
| Aug 15, 2025 | Platinum Biologics LLC | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Aug 11, 2025 | Anhui Hanbon Daily Chemical Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 11, 2025 | Everlaan Organics, Inc. Dba Maple Organics | Center for Drug Evaluation and Research (CDER) | CGMP/OTC/Unapproved New Drugs/Misbranded |
| Aug 11, 2025 | LeMaitre Vascular, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Aug 7, 2025 | DingMoo LLC DBA Dingman’S Dairy | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 6, 2025 | ABBE Laboratories, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 6, 2025 | Fallien Cosmeceuticals Ltd. Dba Fallene Ltd. | Center for Drug Evaluation and Research (CDER) | OTC/Unapproved New Drug/Misbranded |
| Aug 6, 2025 | Kalani AB Dba Kalani Sunwear | Center for Drug Evaluation and Research (CDER) | OTC/Unapproved New Drug/Misbranded |
| Aug 6, 2025 | K & Care Organics | Center for Drug Evaluation and Research (CDER) | OTC/Unapproved New Drug/Misbranded |
| Aug 6, 2025 | Supergoop! | Center for Drug Evaluation and Research (CDER) | OTC/Unapproved New Drug/Misbranded |
| Aug 6, 2025 | Vacation Inc. | Center for Drug Evaluation and Research (CDER) | OTC/Unapproved New Drug/Misbranded |
| Aug 1, 2025 | Confer With | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Aug 1, 2025 | Www.Usaquickmeds.Com | Center for Drug Evaluation and Research (CDER) | Misbranded and Unapproved New Drugs |
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 |
|---|---|---|---|
| Aug 29, 2025 | Bio-Medical Pharmaceutical Manufacturing Corporation | Drugs | United States |
| Aug 29, 2025 | JZ Wholesale, Inc. | Food/Cosmetics | United States |
| Aug 29, 2025 | Lewis Sausage Company, Inc. | Veterinary | United States |
| Aug 29, 2025 | ZACANTA LLC | Food/Cosmetics | United States |
| Aug 28, 2025 | Northern Digital Inc. | Devices | Canada |
| Aug 28, 2025 | RC Outsourcing, LLC | Drugs | United States |
| Aug 28, 2025 | Shandong Want Want Foods Limited | Food/Cosmetics | China |
| Aug 27, 2025 | Exactech, Inc. | Devices | United States |
| Aug 26, 2025 | Magellan Diagnostics, Inc. | Devices | United States |
| Aug 26, 2025 | Quesito El Establo | Food/Cosmetics | United States |
| Aug 23, 2025 | AVEDA AYUR LLP | Food/Cosmetics | India |
| Aug 22, 2025 | Chemco Corporation | Drugs | United States |
| Aug 22, 2025 | EPM Packaging, Inc. | Drugs | United States |
| Aug 22, 2025 | HTO Nevada Inc. | Drugs | United States |
| Aug 22, 2025 | Megsan Labs Private Limited | Drugs | India |
| Aug 22, 2025 | Michael Crimmins, Inc. | Food/Cosmetics | United States |
| Aug 21, 2025 | A1 WAREHOUSE | Tobacco | United States |
| Aug 21, 2025 | ECO FRESH INDUSTRIA E COMERCIO DE ALIMENTOS LTDA | Food/Cosmetics | Brazil |
| Aug 21, 2025 | Enoki King Mushroom Farm Inc. | Food/Cosmetics | United States |
| Aug 21, 2025 | Michele K. Lee Tanner, DVM | Veterinary | United States |
| Aug 21, 2025 | R.R. Importaciones Inc. | Food/Cosmetics | United States |
| Aug 20, 2025 | Mr. Vape USA, LLC | Tobacco | United States |
| Aug 19, 2025 | Aversa's Italian Bakery | Food/Cosmetics | United States |
| Aug 19, 2025 | Diasol, Inc | Devices | United States |
| Aug 18, 2025 | DO & CO Detroit, Inc. | Food/Cosmetics | United States |
| Aug 18, 2025 | DO & CO Detroit, Inc. | Food/Cosmetics | United States |
| Aug 15, 2025 | Dream Distro, LLC | Tobacco | United States |
| Aug 15, 2025 | PACIFIC EXCHANGE DISTRIBUTORS | Food/Cosmetics | United States |
| Aug 15, 2025 | Rojas Inc. | Food/Cosmetics | United States |
| Aug 15, 2025 | Sozinho Dairy Inc. | Veterinary | United States |
| Aug 15, 2025 | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | Drugs | China |
| Aug 14, 2025 | MG GROUP USA | Food/Cosmetics | United States |
| Aug 14, 2025 | SEN WILD AND FARMED FOOD JOINT STOCK COMPANY | Food/Cosmetics | Vietnam |
| Aug 14, 2025 | University Of Pittsburgh Medical Center Centralized Packaging | Drugs | United States |
| Aug 12, 2025 | AQ USA, Inc. | Drugs | United States |
| Aug 12, 2025 | Fareva Morton Grove, Inc. | Drugs | United States |
| Aug 11, 2025 | Moor Distribution, Inc. | Tobacco | United States |
| Aug 8, 2025 | AnazaoHealth Corporation | Drugs | United States |
| Aug 8, 2025 | Boesl Packing Company, Inc. | Veterinary | United States |
| Aug 8, 2025 | Derma Care Research Labs LLC | Drugs | United States |
| Aug 8, 2025 | Fagron Compounding Services | Drugs | United States |
| Aug 8, 2025 | Fresenius Kabi USA, LLC | Devices | United States |
| Aug 8, 2025 | OPS International Inc | Drugs | United States |
| Aug 8, 2025 | Steri-Pharma, LLC | Veterinary | United States |
| Aug 7, 2025 | Hong Qiangxing (Shen Zhen) Electronics Limited | Devices | China |
| Aug 7, 2025 | KMT DISTRIBUTION | Tobacco | United States |
| Aug 5, 2025 | Abiomed, Inc. | Devices | United States |
| Aug 5, 2025 | ART MX, LLC | Food/Cosmetics | United States |
| Aug 5, 2025 | Sikandar Foods | Food/Cosmetics | India |
| Aug 5, 2025 | Winder Laboratories, LLC | Drugs | United States |
| Aug 1, 2025 | ASP Global, LLC. | Devices | United States |
| Aug 1, 2025 | Chemspec Chemicals Private Limited | Drugs | India |
| Aug 1, 2025 | Saol Therapeutics Inc | Devices | 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 117.35(a) | Sanitary operations - Plant sanitation | 32 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 31 |
| 21 CFR 1.502(a) | Develop FSVP | 30 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 27 |
| 21 CFR 117.10 | Personnel | 24 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 23 |
| 21 CFR 117.35(c) | Pest control | 23 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 23 |
| 21 CFR 111.70(b) | Specifications - components | 21 |
| 21 CFR 111.70(e) | Specifications - finished dietary supplement | 21 |
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 |
|---|---|---|---|
| Aug 28, 2025 | Dexcom, Inc. | Devices | A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not… |
| Aug 28, 2025 | Green Lumber Holdings, LLC | Drugs | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 28, 2025 | Siemens Medical Solutions USA, Inc | Devices | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas… |
| Aug 27, 2025 | Middlefield Original Cheese Cooperative | Food | Potential contamination with Listeria monocytogenes |
| Aug 27, 2025 | Middlefield Original Cheese Cooperative | Food | Potential contamination with Listeria monocytogenes |
| Aug 27, 2025 | Middlefield Original Cheese Cooperative | Food | Potential contamination with Listeria monocytogenes |
| Aug 27, 2025 | Middlefield Original Cheese Cooperative | Food | Potential contamination with Listeria monocytogenes |
| Aug 27, 2025 | Middlefield Original Cheese Cooperative | Food | Potential contamination with Listeria monocytogenes |
| Aug 27, 2025 | Middlefield Original Cheese Cooperative | Food | Potential contamination with Listeria monocytogenes |
| Aug 27, 2025 | Middlefield Original Cheese Cooperative | Food | Potential contamination with Listeria monocytogenes |
| Aug 27, 2025 | Middlefield Original Cheese Cooperative | Food | Potential contamination with Listeria monocytogenes |
| Aug 27, 2025 | Middlefield Original Cheese Cooperative | Food | Potential contamination with Listeria monocytogenes |
| Aug 27, 2025 | Unichem Pharmaceuticals USA Inc. | Drugs | Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride… |
| Aug 26, 2025 | Country Eggs, LLC | Food | Shell egg product potentially contaminated with salmonella. |
| Aug 21, 2025 | Latitude 36 Foods | Food | Product contains undeclared Soy and Sesame |
| Aug 21, 2025 | Medline Industries, LP | Devices | The kits contain certain lots of cannula products where the catheter may not retain its shape. |
| Aug 21, 2025 | Taylor Farms Retail, Inc. | Food | Undeclared allergens (sesame and soy). |
| Aug 20, 2025 | Abiomed, Inc. | Devices | Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 20, 2025 | Boston Scientific Corporation | Devices | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a… |
| Aug 18, 2025 | B BRAUN MEDICAL INC | Drugs | Presence of Particulate Matter |
| Aug 18, 2025 | B BRAUN MEDICAL INC | Drugs | Presence of Particulate Matter. |
| Aug 15, 2025 | NEW ACAI AMAZONAS LLC | Food | Potential Salmonella contamination |
| Aug 13, 2025 | Fresh & Ready Foods LLC | Food | undeclared allergen (Wheat and Milk) on ready to eat sandwiches. |
| Aug 13, 2025 | Fresh & Ready Foods LLC | Food | undeclared allergen (Wheat and Milk) on ready to eat sandwiches. |
| Aug 13, 2025 | Fresh & Ready Foods LLC | Food | undeclared allergen (Wheat and Milk) on ready to eat sandwiches. |
| Aug 13, 2025 | Fresh & Ready Foods LLC | Food | undeclared allergen (Wheat) on ready to eat sandwiches. |
| Aug 12, 2025 | Max Mobility LLC | Devices | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of… |
| Aug 12, 2025 | Max Mobility LLC | Devices | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of… |
| Aug 12, 2025 | Max Mobility LLC | Devices | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of… |
| Aug 12, 2025 | Quesito El Establo | Food | Product was manufactured and held under insanitary conditions. Product may be contaminated with Listeria monocytogenes. |
| Aug 12, 2025 | Wegmans Food Markets, Inc. | Food | Products may be contaminated with Listeria monocytogenes |
| Aug 12, 2025 | Wegmans Food Markets, Inc. | Food | Products may be contaminated with Listeria monocytogenes |
| Aug 12, 2025 | Wegmans Food Markets, Inc. | Food | Products may be contaminated with Listeria monocytogenes |
| Aug 12, 2025 | Wegmans Food Markets, Inc. | Food | Products may be contaminated with Listeria monocytogenes |
| Aug 11, 2025 | Fromi Usa | Food | Product may be contaminated with Listeria monocytogenes |
| Aug 8, 2025 | Medline Industries, LP | Devices | Convenience kits labeled as sterile have not gone through the sterilization process. |
| Aug 8, 2025 | Medline Industries, LP | Devices | Convenience kits labeled as sterile have not gone through the sterilization process. |
| Aug 6, 2025 | Medtronic Perfusion Systems | Devices | The catheters may not retain their shape. |
| Aug 6, 2025 | Medtronic Perfusion Systems | Devices | The catheters may not retain their shape. |
| Aug 6, 2025 | Medtronic Perfusion Systems | Devices | The catheters may not retain their shape. |
| Aug 6, 2025 | Olympus Corporation Of The Americas | Devices | Potential for undetected, deformed a-traumatic tips. |
| Aug 4, 2025 | Baxter Healthcare Corporation | Devices | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe… |
| Aug 4, 2025 | Baxter Healthcare Corporation | Devices | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe… |
| Aug 4, 2025 | Baxter Healthcare Corporation | Devices | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe… |
| Aug 4, 2025 | Neuhaus Nv | Food | Product contains undeclared wheat. |
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