Olympus MAJ-210 Biopsy Valve Recall
Olympus single-use biopsy valves (Model MAJ-210) may shed rubber fragments during use. Healthcare providers should stop using affected units and contact Olympus …
Olympus Corporation of the Americas
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.
138 recalls · updated Jul 14, 2026
Olympus MAJ-1218 Biopsy Valve Recall
Olympus Single Use Biopsy Valve (Model MAJ-1218) has been recalled because rubber fragments can detach during use. If fragments enter the endoscope or are not …
Olympus Corporation of the Americas
B. Braun CESK Harris Methodist Recall
B. Braun's CESK Harris Methodist adhesive component (model 555498) contains tubing that may crack during manufacturing, making it unusable. The defect was …
B Braun Medical Inc
Abiomed Impella RP Flex SmartAssist Recall
Abiomed has recalled the Impella RP Flex with SmartAssist heart pump (Product Code 1000323) because a pressure sensor inside the device may malfunction and give …
Abiomed, Inc.
I.T.S. HCS Headless Compression Screw Recall
I.T.S. GmbH's HCS Headless Compression Screw System may heat up more than expected during MRI scans. The manufacturer has updated safety information to reflect …
I.T.S. GmbH
I.T.S. Foot Locking Plates & Hallux Osteotomy Recall
The FLS Foot Locking Plates System and HOL Hallux Osteotomy Locking Plate may heat up more than expected during an MRI scan. Updated safety testing found higher …
I.T.S. GmbH
GEM Premier 5000 PAK Cartridge Recall
GEM Premier 5000 PAK cartridges may repeatedly eject during warm-up due to detection errors, requiring cartridge replacement and potentially delaying test …
Instrumentation Laboratory
First Aid Only BZK Antiseptic Towelette Recall
First Aid Only BZK Antiseptic Towelettes (5x7 bulk size) are being recalled due to manufacturing defects. The product may not meet quality standards for an …
ACME UNITED CORPORATION
MediHoney Gel Leptospermum Recall
MediHoney Gel with Active Leptospermum Honey wound dressings (models 31805 and 31815) are being recalled due to potential packaging failures that could …
Integra LifeSciences Corp. (NeuroSciences)
Endo-Model Replacement Plateau Recall
The Endo-Model Replacement Plateau implant (Item Number 15-0027/11) is being recalled because the bushing on the plateau screw can detach from the shaft due to …
Waldemar Link GmbH & Co. KG (Mfg Site)
Medline Dialysis On/Off Kit Recall
Medline Dialysis On/Off Kits with Tego Connectors may have defective silicone seals that can tear or dome, blocking fluid flow during dialysis or causing …
Medline Industries, LP
Medline Dialysis Dressing Change Kit Recall
Medline dialysis dressing change convenience kits with Tego Connectors may have defective silicone seals that can tear or dome, blocking the fluid path and …
Medline Industries, LP
Medline Convenience Kits Recall
Medline is recalling multiple surgical convenience kits due to sterilization equipment calibration issues that may have compromised the sterility of these …
Medline Industries, LP
Medline Cardiac Surgery Kits Recall
Medline has recalled multiple surgical convenience kits used in cardiac procedures due to sterilization equipment calibration issues that may compromise the …
Medline Industries, LP
Olympus Sphincterotome V Device Recall
Olympus Single Use 3-Lumen Sphincterotome V devices may deform and lose performance if they were not properly thermoformed during manufacturing. These …
Olympus Corporation of the Americas
Olympus Sphincterotome V Recall
Olympus has recalled certain Single Use 3-Lumen Sphincterotome V instruments because some units may not have been properly heat-formed, causing them to deform …
Olympus Corporation of the Americas
Olympus Sphincterotome Recall KD-401Q
Olympus Disposable Triple Lumen Sphincterotome Model KD-401Q-0330 may deform and lose performance if it was not properly thermoformed during manufacturing. This …
Olympus Corporation of the Americas
Medline Convenience Kits Recall
Medline Convenience Kits (Model DYNJ50806L) have been recalled because sterilization equipment calibration problems may have compromised the sterility of these …
Medline Industries, LP
Medline PPE Kit Model DYK1011945P Recall
Medline Convenience Kits PPE Kit (Model DYK1011945P) may not be properly sterilized due to calibration issues with the sterilization equipment. This could …
Medline Industries, LP
Medline Convenience Kits Recall
Medline is recalling Lithotomy Packs and Lap Basin kits because sterilization equipment calibration problems may have compromised the sterility of these medical …
Medline Industries, LP
Medline Triple Lumen Insertion Kit Recall
Medline is recalling Triple Lumen Insertion Kits due to sterilization equipment calibration issues that may have compromised the sterility of the devices. Use …
Medline Industries, LP
Medline Surgical Biopsy Kits Recall
Medline is recalling multiple surgical and biopsy kits due to potential sterilization issues. Equipment calibration problems could affect whether these sterile …
Medline Industries, LP
WHILL Model C2 Powered Wheelchair Recall
WHILL is recalling certain Model C2 powered wheelchairs because a security vulnerability in the chair's Bluetooth Low Energy (BLE) communication could allow an …
WHILL, INC.
Medline Dressing Change Kit Recall
Medline medical convenience kits are being recalled because they contain BD ChloraPrep Triple Swabsticks with potentially open seals on the applicator …
Medline Industries, LP
LSL Healthcare Central Line Dressing Kit Recall
LSL Healthcare's Central Line Dressing Kit (Model 2519CP) is being recalled because the BD ChloraPrep Triple Swabsticks component inside has packaging with an …
LSL Healthcare Inc.
Canon VANTAGE GALAN 3T MRI Recall
Canon Medical's VANTAGE GALAN 3T MRI machines may develop ice in the magnet venting system. During an emergency shutdown (quench), helium gas could become …
Canon Medical System, USA, INC.
Genesis Push-In Suture Anchor Recall
Genesis Push-In Suture Anchors manufactured by Aju Pharm Co., Ltd. are being recalled due to reports of device failure, including anchor breakage, bending, …
Aju Pharm Co., Ltd.
AlternatiV+ Screw-In Anchor Recall
Aju Pharm's AlternatiV+ Screw-In Anchor surgical implant has been recalled due to reports of device failure, including breakage, bending, pull-out, and suture …
Aju Pharm Co., Ltd.
Medline Strykeflow 2 Suction Irrigator Recall
Medline robotics urology prostate kits containing Stryker Strykeflow 2 Suction Irrigators may leak or emit vaporized saline during use due to a 2024 design …
Medline Industries, LP
Vortex Surgical 25GA Convenience Kit Recall
Vortex Surgical 25GA Convenience Kits may have voids in the Tyvek pouch seals, compromising the sterile barrier and risking bacterial contamination. This could …
Vortex Surgical Inc.
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