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FDA Warning Letters, 483s and Recalls: June 2023

FDA enforcement records dated June 2023: 44 warning letters outside tobacco (plus 27 tobacco letters), 38 OAI inspections and 109 Class I recalls. FDA publishes some records weeks after their date, so recent months can still grow.

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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.

DateCompanyIssuing officeSubject
Jun 30, 2023Baits And Sea Foods, S.A.Center for Food Safety and Applied Nutrition (CFSAN)Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Jun 30, 2023Marumo Co., Ltd.Center for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated
Jun 30, 2023Wisetrade CorporationDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
Jun 29, 2023Delta Munchies LLCCenter for Food Safety and Applied Nutrition (CFSAN)Interstate Commerce/Food/Adulterated
Jun 29, 2023Dr. Smoke, LLC Aka Dr. S, LLCCenter for Food Safety and Applied Nutrition (CFSAN)Interstate Commerce/Food/Adulterated
Jun 29, 2023Exclusive Hemp Farms/Oshipt.ComCenter for Food Safety and Applied Nutrition (CFSAN)Interstate Commerce/Food/Adulterated
Jun 29, 2023Nikte’S Wholesale, LLCCenter for Food Safety and Applied Nutrition (CFSAN)Interstate Commerce/Food/Adulterated
Jun 29, 2023North Carolina Hemp Exchange, LLC Dba NC Hemp ShoppeCenter for Food Safety and Applied Nutrition (CFSAN)Interstate Commerce/Food/Adulterated
Jun 29, 2023The Haunted Vapor RoomCenter for Food Safety and Applied Nutrition (CFSAN)Interstate Commerce/Food/Adulterated
Jun 28, 2023Eden’S Answers, Inc.Division of Human and Animal Food Operations East VCGMP/Dietary Supplement/Adulterated
Jun 28, 2023Fuller Industries Inc.Division of Pharmaceutical Quality Operations IIICGMP/Finished Pharmaceuticals/Adulterated
Jun 27, 2023Edge Biologicals Inc.Division of Medical Device and Radiological Health Operations CentralCGMP/QSR/Medical Devices/Adulterated
Jun 27, 2023Fukusui Shoji Ltd.Center for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated
Jun 27, 2023The New Hope Center For Reproductive MedicineDivision of Biological Products Operations IDeviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Jun 26, 2023Amor Nino Foods, Inc.Division of Human and Animal Food Operations West VSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Jun 26, 2023Lone Pine FarmDivision of Human and Animal Food Operations West IIPHS Act/Shell Egg Regulation/Adulterated
Jun 26, 2023Lydia Co. Ltd.Center for Drug Evaluation and Research | CDERFailure to Register and List
Jun 22, 2023Five Leaf Pet Botanicals, Inc.Center for Veterinary MedicineUnapproved New Animal Drug Products
Jun 22, 2023Ocalsa Transport & Logistics, LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jun 22, 2023Suprimo ImportsCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Jun 21, 2023Fruits Tress, Inc.Division of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jun 21, 2023NAFTA Distributors Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Jun 21, 2023Porfirios Italian Foods, Inc.Division of Human and Animal Food Operations East IICGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Jun 21, 2023Row1 Inc. Dba Regenative LabsDivision of Biological Products Operations IDeviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Jun 21, 2023ZYTO Technologies, Inc.Division of Medical Device and Radiological Health Operations WestInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Jun 20, 2023Chengdu KeCheng Fine Chemicals Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Jun 15, 2023Healthtex Distributors, Inc.Division of Human and Animal Food Operations East IVCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Jun 14, 2023Cheshni Foods LLCDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Jun 14, 2023Randy J. Epstein, M.D./Chicago Cornea Consultants, Ltd.Center for Drug Evaluation and Research | CDERClinical Investigator (Sponsor)
Jun 12, 2023Lacteos Mi Chalatenango, Inc.Division of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Jun 12, 2023Moises GardeaDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jun 12, 2023New Manna FoodDivision of Human and Animal Food Operations West VSeafood HACCP/CGMP for Foods/Adulterated/Misbranded
Jun 12, 2023Vitang Technology LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jun 12, 2023Warrior Labz SARMSCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Jun 9, 2023Schwebel Baking CompanyDivision of Human and Animal Food Operations East VCGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Jun 8, 2023Safe Chain Solutions, LLCDivision of Pharmaceutical Quality Operations IDrug Product/Adulterated
Jun 6, 2023Pharmacy Plus, Inc., Dba Vital Care CompounderDivision of Pharmaceutical Quality Operations IICompounding Pharmacy/Adulterated Drug Products
Jun 5, 2023Centaur Pharmaceuticals Private Ltd.Center for Drug Evaluation and Research | CDERCGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Jun 5, 2023Stratus Biosystems, LLC Dba CellGenuity Regenerative ScienceDivision of Biological Products Operations IIDeviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Jun 2, 2023Hekma Center, LLCCenter for Food Safety and Applied Nutrition (CFSAN)New Drugs/Dietary Supplements/Food Labeling/Misbranded
Jun 1, 2023A&Z Pharmaceutical, Inc.Division of Human and Animal Food Operations East INew Drug/Misbranded
Jun 1, 2023Ming Fai Industrial Co LTDCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jun 1, 2023Mr. Lulu LLCDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Jun 1, 2023RenatiLabs Inc.Division of Biological Products Operations IDeviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

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.

DateFacilityProduct typeCountry
Jun 30, 2023Dr. Joel Kaplan, Inc.DevicesUnited States
Jun 30, 2023ISOThrive, Inc.DrugsUnited States
Jun 30, 2023Legacy Pharmaceutical Packaging LLCDrugsUnited States
Jun 30, 2023Regenerative Processing Plant, LLCDrugsUnited States
Jun 29, 2023Curtis JacquotFood/CosmeticsUnited States
Jun 29, 2023ReConserve Of Maryland, Inc.VeterinaryUnited States
Jun 28, 2023Kari-Fresh LLCFood/CosmeticsUnited States
Jun 28, 2023SterRx, LLCDrugsUnited States
Jun 23, 2023Laboratorio Reig Jofre S.A.DrugsSpain
Jun 23, 2023Namita A. Goyal, M.D.BiologicsUnited States
Jun 23, 2023PESCAMOZ LDAFood/CosmeticsMozambique
Jun 23, 2023Regenerative Processing Plant LLCBiologicsUnited States
Jun 22, 2023KL Labs, LLCTobaccoUnited States
Jun 22, 2023Marion Mullet FarmVeterinaryUnited States
Jun 22, 2023Pharmasept Medical Products 1995 Ltd.DevicesIsrael
Jun 22, 2023Safa Goods LLCTobaccoUnited States
Jun 22, 2023Stepac L.A., LTD.DevicesIsrael
Jun 22, 2023Techlem Medical CorporationDevicesCanada
Jun 21, 2023Martin Farm - Konrad MartinVeterinaryUnited States
Jun 20, 2023Astral SteriTech Private Ltd.DrugsIndia
Jun 15, 2023Acrostak (Schweiz) AGDevicesSwitzerland
Jun 15, 2023Datascope Corp.DevicesUnited States
Jun 15, 2023EMPIRE IMPORTS LLCTobaccoUnited States
Jun 15, 2023The Juice BarTobaccoUnited States
Jun 14, 2023eCig SourceTobaccoUnited States
Jun 13, 2023Agena Bioscience, Inc.DevicesUnited States
Jun 9, 2023D&A Distribution, LLC D/B/A Strictly E-CigTobaccoUnited States
Jun 9, 2023Samhall ABDevicesSweden
Jun 9, 2023Shima Laboratories Co., Ltd.DevicesJapan
Jun 9, 2023TERRAGENE S.A.DevicesArgentina
Jun 8, 2023Aarti PhosphatesDrugsIndia
Jun 8, 2023City Technology Ltd.DevicesUnited Kingdom
Jun 8, 2023Gold Coast Distributors, Inc.Food/CosmeticsUnited States
Jun 8, 2023Texas Aloe Corporation, Inc.Food/CosmeticsUnited States
Jun 8, 2023Trexo Robotics Holdings Inc.DevicesCanada
Jun 7, 2023Sonesta Medical ABDevicesSweden
Jun 6, 2023Effingham EquityVeterinaryUnited States
Jun 1, 2023W.S. Badger Company, Inc.DrugsUnited States

Most-cited Form 483 sections

The CFR sections FDA investigators cited most often in inspections that ended this month.

CFR sectionObservationCitations
21 CFR 1.502(a)Develop FSVP76
21 CFR 820.100(a)Lack of or inadequate procedures26
21 CFR 820.198(a)Lack of or inadequate complaint procedures22
FDCA 402(a)(4)Records review prior to shipment for slaughter22
21 CFR 123.6(b)No HACCP plan21
21 CFR 123.11(b)Sanitation monitoring documentation19
21 CFR 1.505(a)(2)Evaluation - performance, risk18
21 CFR 1.506(d)(1)(i)Verification activity frequency17
21 CFR 117.35(a)Sanitary operations - Plant sanitation16
21 CFR 117.35(c)Pest control15

Class I recalls

Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.

DateFirmProduct typeReason
Jun 30, 2023Saffron Inc.FoodThe firm was notified that their labels do not list the allergens wheat and sesame.
Jun 29, 2023Abiomed, Inc.DevicesA higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on…
Jun 29, 2023Freshy Foods, LLCFoodpotential contamination of Listeria monocytogenes
Jun 29, 2023Freshy Foods, LLCFoodpotential contamination of Listeria monocytogenes
Jun 29, 2023Freshy Foods, LLCFoodpotential contamination of Listeria monocytogenes
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 28, 2023Covidien LPDevicesCatheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a…
Jun 27, 2023Cipla USA, Inc.DrugsDefective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Jun 26, 2023Rose Street Bread LabFoodBread contains undeclared sesame.
Jun 23, 2023Estancia HoldingsFoodPossible microbiological contamination, specifically Listeria monocytogenes.
Jun 23, 2023Lupin Pharmaceuticals Inc.DrugsFailed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid…
Jun 22, 2023FMA International LLCFoodcheese contaminated with Listeria monocytogenes
Jun 21, 2023SANTOS FROZEN FOODSFoodUndeclared Milk and Sesame Seeds
Jun 21, 2023SANTOS FROZEN FOODSFoodUndeclared Milk and Sesame Seeds
Jun 21, 2023SANTOS FROZEN FOODSFoodUndeclared Milk and Sesame Seeds
Jun 21, 2023Scenic Fruit Company, LLCFoodPotential for contamination with Listeria monocytogenes. Pineapples are recalled by supplier Sunrise Growers Inc.
Jun 21, 2023Scenic Fruit Company, LLCFoodPotential for contamination with Listeria monocytogenes. Pineapples are recalled by supplier Sunrise Growers Inc.
Jun 21, 2023Townsend Farms IncFoodPotential to be contaminated with Listeria monocytogenes.
Jun 21, 2023Townsend Farms IncFoodPotential to be contaminated with Listeria monocytogenes.
Jun 21, 2023Townsend Farms IncFoodPotential to be contaminated with Listeria monocytogenes.
Jun 21, 2023Townsend Farms IncFoodPotential to be contaminated with Listeria monocytogenes.
Jun 16, 2023Frito-Lay, Inc. HeadquartersFoodUndeclared milk
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 16, 2023SunOpta Grains And Foods Inc.FoodFruit products have the potential to be contaminated with Listeria monocytogenes.
Jun 15, 2023Baxter Healthcare CorporationDevicesA medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ…
Jun 15, 2023Baxter Healthcare CorporationDevicesA medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ…
Jun 15, 2023Hamilton Medical, Inc.DevicesDue to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior…
Jun 15, 2023Hamilton Medical, Inc.DevicesDue to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior…
Jun 15, 2023Hamilton Medical, Inc.DevicesDue to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior…
Jun 15, 2023Hamilton Medical, Inc.DevicesDue to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior…
Jun 14, 2023Abiomed, Inc.DevicesThere is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve…
Jun 14, 2023Abiomed, Inc.DevicesThere is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve…
Jun 14, 2023Abiomed, Inc.DevicesThere is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve…
Jun 14, 2023Abiomed, Inc.DevicesThere is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve…
Jun 14, 2023Abiomed, Inc.DevicesThere is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve…
Jun 14, 2023Abiomed, Inc.DevicesThere is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve…
Jun 12, 2023AbbottDevicesThere is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS…
Jun 12, 2023Draeger Medical, Inc.DevicesDraeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
Jun 12, 2023Foremost Foods International, Inc.FoodPotential choking hazard
Jun 12, 2023Foremost Foods International, Inc.FoodPotential choking hazard
Jun 12, 2023Foremost Foods International, Inc.FoodPotential choking hazard
Jun 9, 2023Richin Trading IncFoodPotential choking hazard
Jun 9, 2023Richin Trading IncFoodPotential choking hazard
Jun 9, 2023Richin Trading IncFoodPotential choking hazard
Jun 8, 2023Olympus Corporation Of The AmericasDevicesThere have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Jun 8, 2023Olympus Corporation Of The AmericasDevicesThere have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Jun 8, 2023Olympus Corporation Of The AmericasDevicesThere have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Jun 8, 2023Olympus Corporation Of The AmericasDevicesThere have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Jun 8, 2023Olympus Corporation Of The AmericasDevicesThere have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Jun 8, 2023Olympus Corporation Of The AmericasDevicesThere have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Jun 8, 2023Olympus Corporation Of The AmericasDevicesThere have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Jun 7, 2023Oregon Potato CompanyFoodPotential contamination with Hepatitis A.
Jun 7, 2023Oregon Potato CompanyFoodPotential contamination with Hepatitis A.
Jun 7, 2023Oregon Potato CompanyFoodPotential contamination with Hepatitis A.
Jun 7, 2023Oregon Potato CompanyFoodPotential contamination with Hepatitis A.
Jun 7, 2023Oregon Potato CompanyFoodPotential contamination with Hepatitis A.
Jun 6, 2023DATEX--OHMEDA, INC.DevicesPrior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators…
Jun 6, 2023DATEX--OHMEDA, INC.DevicesPrior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators…
Jun 5, 2023Datascope Corp.DevicesIABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the…
Jun 5, 2023Datascope Corp.DevicesAn unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board…
Jun 5, 2023Datascope Corp.DevicesIABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the…
Jun 5, 2023Datascope Corp.DevicesAn unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board…
Jun 5, 2023Wawona Frozen Foods Inc.FoodProduct may contain Hepatitis A

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.