Medicine Recalls

Hamilton Medical is recalling certain coaxial breathing sets due to a defect that may cause cracks in the inner tube, risking patient rebreathing exhaled gases.

A blocked manometer port on the Ambu SPUR II resuscitator may delay ventilation or cause barotrauma

Abbott Medical is removing power cords associated with the HeartMate Mobile Power Unit due to a potential risk of the cord not locking into place.

Extended Tip Applicator recall due to potential non-sterile product and high endotoxin levels. May cause inflammation or infection if used.

ICU Medical is correcting the Plum Duo infusion system due to pump software issues that may cause the device to become unresponsive.

Hamilton is repairing certain HAMILTON-C6 ventilators to replace a defective circuit board that can interrupt ventilation, risking serious injury or death.

The FDA is reminding the public about the safe use of hyperbaric oxygen therapy devices and is providing recommendations to help reduce potential risks.

On August 22, 2025,the US FDA's Center for Biologics Evaluation and Research has suspended the biologics license for Valneva Austria GmbH's Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in November of 2023 for the prevention of...

Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis due to risk of resistance during device withdrawal

For Immediate Release - BETHLEHEM, PA - August 19, 2025 - B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL,and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the...

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Correction Issued for the Novum IQ Large Volume Pumps, Syringe Pumps

Draeger recalls SafeStar, TwinStar filters due to misleading carbon dioxide waveforms, may result in unnecessary treatment, potentially causing harm or death

SAN DIEGO - August 7, 2025 - Tandem Diabetes Care, Inc. (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery.

DermaRite Industries, LLC is voluntarily recalling individual lots of products in the table below due to microbial contamination identified as Burkholderia cepecia.

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Removes Recommended Pause in Use and Approves Required Updated Labeling: FDA Safety Communication

BiPAP A30, A40, and V30 devices may shut down due to a Ventilator Interruptions, leading to therapy loss. May cause serious injury or death.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Recall affects certain Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters

Boston Scientific has issued a letter to affected customers recommending all lots of certain WATCHMAN Access Systems have updated use instructions

FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use. Class-Wide Action Will Further Emphasize and Characterize Risks of Long-Term Use to Help Patients, Health Care Professionals Make Informed Treatment Decisions: Drug Safety...

Ethicon Endo-Surgery is correcting the Endopath Echelon due to a potential surgical lockout that stops cutting or stapling and requires extra removal steps.

Edwards recalls arterial cannulae due to risk of wire exposure that may cause serious patient harm.

Baxter is removing mobile lift components due to risk of false attachment, which may result in patient injury due to falls.

Medline Craniotomy Kits are procedure convenience kits. Kits containing the Codman Disposable Perforator are being corrected by Medline Industries.