ChloraPrep FREPP Applicators Recall
ChloraPrep FREPP sterile skin antiseptic applicators were distributed without proper sterilization, posing a risk of infection. These applicators are used …
CareFusion 213, LLC
Medical Device recalls
The newest FDA medical device recalls, in plain English. We list the device, the affected model or lot numbers, the FDA classification, and the corrective action the manufacturer is taking.
125 recalls · updated Jun 11, 2026
Aquacel Ag Surgical SP Recall
ConvaTec is recalling Aquacel Ag Surgical SP surgical dressings (REF 413556, 9cm x 15cm size) because some were made thicker than the design specification. The …
ConvaTec, Inc
SUNS International SS6291 Elevator Switch Recall
SUNS International is recalling SS6291 Solenoid Interlock Switches used in residential elevators because the switch can get stuck in a retracted position, …
SUNS SS6291 Solenoid Interlock Switches
Remel GC Agar Base Recall
Remel GC Agar Base laboratory media may not properly recover some strains of Neisseria gonorrhoeae bacteria, potentially leading to missed or delayed diagnoses …
Remel, Inc
Medline Swan-Ganz Catheter Kits Recall
Medline Convenience kits containing Swan-Ganz catheters are being recalled due to failures in the blue proximal injectate lumen hub that can leak or break, …
Medline Industries, LP
Medline Swan-Ganz Catheters Recall
Medline Convenience kits containing Swan-Ganz catheters are being recalled because the blue proximal injectate lumen hub can leak, break, or fail, risking …
Medline Industries, LP
Medline Convenience Kits Recall
Medline Convenience Kits containing Huons Lidocaine HCL Injection have been recalled due to quality issues found during an FDA inspection of the supplier's …
Medline Industries, LP
CRE Pro Wireguided Boston Scientific Recall
Boston Scientific's CRE Pro Wireguided devices (12-15mm, 240cm) have a potential sterile packaging breach. If the pouch was damaged or unsealed, the device …
Boston Scientific Corporation
Bard Poly Midline Catheter Recall
Bard Access Systems is recalling Poly Midline Catheters (models CK000495A and CK000566) because the lidocaine supplied with these catheters was made under …
Bard Access Systems, Inc.
RayCare 2024A SP1 Oncology Software Recall
RayCare 2024A SP1 oncology software can lose patient treatment data if beam set delivery notes are edited at the same time or changed during an active treatment …
RAYSEARCH LABORATORIES AB
Medtronic O-arm O2 Imaging System Recall
The Medtronic O-arm O2 Imaging System (Model BI70002000) can produce distorted or incorrect images due to a firmware defect in its detector panel. This imaging …
Medtronic Navigation, Inc.-Boxborough
Inspire Stimulation Lead 4063 Recall
Inspire Stimulation Lead (Model 4063) devices are labeled with incorrect expiration dates that extend beyond their validated three-year shelf life. Using an …
Inspire Medical Systems Inc.
Pilling Wecksorb Neurosponges Recall
Pilling Wecksorb Neurosponges, absorbent cotton sponges used to protect brain and spinal cord tissue during surgery, may contain unsafe levels of endotoxins, …
TELEFLEX LLC
Fresenius Bicarby Dialysate RFP-400-G Recall
Fresenius Bicarby Dialysate (Model RFP-400-G) has an incorrect barcode label that could lead to the wrong potassium concentration being used during dialysis. …
Fresenius Medical Care Holdings, Inc.
Draeger Atlan A350XL Anesthesia Workstation Recall
Draeger has recalled the Atlan A350XL anesthesia workstation (model 8621600) because the device may signal a piston ventilator failure before use, or the …
Draeger, Inc.
B. Braun Spinocan Spinal Needle Kit Recall
B. Braun Medical is recalling three Spinocan spinal needle procedure kits that contain Bupivacaine 0.75% with Dextrose 8.25% injection. The bupivacaine inside …
B Braun Medical Inc
Medline Medical Procedure Kits Recall
Medline Medical Procedure Kits used in cardiac and vascular surgeries have defects in catheter quality, including surface irregularities, loose connectors, and …
Medline Industries, LP
CGuard Prime Carotid Stent Recall
The CGuard Prime Carotid Stent System (model CND0840) may encounter deployment complications that prevent the stent from being placed properly during the …
INSPIREMD Inc
Surgify Halo Surgical Burr Recall
Surgify Halo 5.4 mm Medium burr drills (Model 54.085.SHD.H1) used in spinal surgery can break during the procedure. A broken burr could complicate surgery or …
SURGIFY MEDICAL OY
Residential Elevators StrikeLock Door Lock Recall
Residential Elevators is recalling its StrikeLock hoistway door locking device, used on residential elevator landing doors. The defective lock can allow the …
Residential Elevators StrikeLock Hoistway Door Locking Device
Avanos MIC Safety PEG Kit Recall
Avanos Medical's MIC Safety Percutaneous Endoscopic Gastrostomy (PEG) Kit 24 Fr PUSH OTW (Model 7170-24) contains lidocaine hydrochloride injection with quality …
Avanos Medical, Inc.
Avanos CORFLO Safety PEG Kit Recall
Avanos Medical is recalling CORFLO Safety PEG kits with ENFit connectors because they contain lidocaine injection from a supplier with quality issues. This …
Avanos Medical, Inc.
CORFLO Safety PEG Kit ENFit Connector Recall
Avanos Medical is recalling the CORFLO Safety PEG Kit with ENFit Connector (Model 50-4320) because some kits contain lidocaine hydrochloride injection with …
Avanos Medical, Inc.
BD Spinal Tray Whitacre Needle 405645 Recall
Becton Dickinson is recalling a spinal anesthesia tray because one of its drug components, bupivacaine hydrochloride in dextrose injection, was made at a …
Becton Dickinson & Company
Covidien Mon-a-Therm Temperature Probe Recall
Covidien Mon-a-Therm temperature probe (9 Fr, REF 90050) was sold without FDA clearance. The company initiated a voluntary withdrawal because these devices lack …
Covidien LLC
BD PurPrep Povidone-Iodine Recall
BD PurPrep povidone-iodine sterile skin prep solution (25 applicators per carton) may not be sterile due to potential product contamination. Using a non-sterile …
CareFusion 213, LLC
BD PurPrep Povidone-Iodine Recall
BD PurPrep povidone-iodine sterile solution applicators (10.5 mL, 25-pack) are being recalled because the manufacturer cannot confirm they are properly …
CareFusion 213, LLC
GE Allia IGS 3 Pulse X-ray System Recall
An electrical cable defect in certain GE Allia IGS 3 Pulse angiographic X-ray systems equipped with Gaia generators poses a risk of electrical shock to service …
GE Medical Systems, LLC
Philips SmartPath dStream MRE Recall
Philips SmartPath to dStream 3.0T MR Elastography systems can produce incorrect stiffness measurements when certain image settings are used together. This may …
Philips North America
Physio-Control LIFEPAK Defibrillator Recall 2026
Physio-Control is recalling certain LIFEPAK defibrillators that were serviced between July 2023 and November 2025 without confirmed completion of a required …
Physio-Control, Inc.
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