The LifeSPARC System is being recalled because users can inadvertently cause extended pump stop. A software update will address this issue.

The LifeSPARC System is being recalled for risk that users can inadvertently cause extended pump stop when replacing the controller after software malfunction.

The LifeSPARC System is being recalled because users can inadvertently cause extended pump stop. A software update will address this issue.

RSDL Kits may leak, reducing the effectiveness of the kit when it is needed or exposing users unnecessarily to the decontamination lotion.

2023 Medical Device Recalls

Blood may enter the Cardiosave IABP through a damaged balloon catheter, causing pump shut-down, or patient exposure to helium or cross-contaminated blood

The Intera 3000 Hepatic Artery Infusion Pump is being recalled after reports that it has a faster than expected flow rate.

Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used to manufacture or compound prescription products, to the user level. Customer complaints have found the product to be discolored.

Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of two potential issues with CADDTM Infusion System Infusion Sets related to potential lack of delivery or underdelivery and false no disposable attached (NOA) alarms. The letter details the issues, the aff

Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer level. FDA analysis found the p

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride Injection, USP, 1.5 g/vial Single Dose Flip-top Vial, lot 33045BA, to the user level due to two visible glass particulates observed in a single vial.

Accord Healthcare, Inc. is voluntarily recalling a single lot of Daptomycin for Injection 500 mg/vial, and Daptomycin for Injection 350 mg/vial product contained in cartons imprinted with lot # R2200232 Exp: 01/2025 to the consumer/user level.

Certain reworked Trilogy ventilators have two recent issues that may cause blockage or debris in the airpath.

Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no rep

Mighty Bliss electric heating pads are being recalled because they may cause injuries including electric shocks, burns, rashes and irritation.

Batteries on the Arrow AutoCAT 2 and AC3 Intra-Aortic Balloon Pumps deplete faster than expected, which may cause the pump to stop during patient transport.

An inadequate connection between housings in Arrow multi-lumen central venous access and catheter kits may cause a cross lumen leak that can harm patients.

Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, our molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26th, 2022 thro

The FDA posts letters to health care providers about the safe use of medical devices.

Thermo Scientific Gram Negative IVD AST Sensititre Plate is being recalled for a risk of potential false susceptible results when tested with certain antibiotics.