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Showing 2301–2320 of 3039 results

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Clindamycin HCl Capsules (RemedyRePack) - CGMP Issues (2025)

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

Class IIModerate

FDAApr 22, 2025FL, PA, VA• RemedyRePack Inc.

Catalyst+ C4D Software (C-RAD) – Scanning Equipment Error (2025)

Software issue with scanning equipment that can results in the filed rotation not being applied correctly.

FDAApr 22, 2025Nationwide• C-RAD POSITIONING AB Bredgrand 18 Uppsala Sweden

Codman Disposable Perforator Kit (Medline) – Weld Inadequacy (2025)

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

High

FDAApr 22, 2025CA, FL, IL +10 more• MEDLINE INDUSTRIES, LP Northfield

Endopath Echelon Vascular Reload (Ethicon) – Instrument Lockout (2025)

Laceration Risk

Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.

FDAApr 22, 2025Nationwide• Ethicon Endo-Surgery Inc

Plum Solos Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

FDAApr 22, 2025Nationwide• ICU Medical, Inc.

Plum Duo Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

FDAApr 22, 2025Nationwide• ICU Medical, Inc.

Monkfish Liver (JJWV Marketing) – Undeclared Milk (2025)

Undeclared Allergen

Undeclared allergen ingredient (milk)

FDAApr 21, 2025CA• JJWV Marketing Corporation

Tirofiban Hydrochloride Injection (Eugia US) - Stability Concern (2025)

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Class IIModerate

FDAApr 21, 2025Nationwide• Eugia US LLC

Tirofiban Hydrochloride Injection (Eugia US) - Stability Concern (2025)

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Class IIModerate

FDAApr 21, 2025Nationwide• Eugia US LLC

BENLYSTA Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

PROLIA Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

EVENITY Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

Precision Sampling Set (Capnia) – Contamination Risk (2025)

Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.

FDAApr 21, 2025Nationwide• Capnia Inc

BD Cathena IV Catheter (BD) – Septum Defect Risk (2025)

Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.

FDAApr 21, 2025Nationwide• Becton Dickinson Infusion Therapy Systems, Inc.

Lower Extremity Implant (American Contract) – EO/ECH Residuals (2025)

Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.

FDAApr 21, 2025Nationwide• American Contract Systems, Inc.

niCARdipine Hydrochloride Injection (American Regent) - Sterility Risk (2025)

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Class IIModerate

FDAApr 18, 2025Nationwide• American Regent, Inc.

niCARdipine Hydrochloride Injection (American Regent) - Sterility Risk (2025)

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Class IIModerate

FDAApr 18, 2025Nationwide• American Regent, Inc.

Clindamycin Hydrochloride Capsules (Preferred Pharmaceuticals) - CGMP Issues (2025)

cGMP Deviations

Class IIModerate

FDAApr 18, 2025Nationwide• Preferred Pharmaceuticals, Inc.

Timolol Maleate Eye Solution (FDC Limited) - Defective Container (2025)

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Class IIModerate

FDAApr 18, 2025Nationwide• FDC Limited

Tornado Embolization Microcoil (Cook) – Sizing Error (2025)

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.

FDAApr 17, 2025Nationwide• Cook Incorporated

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