All recall categories

Medical device recalls

Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.

13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.

Medical devices

Reported May 13, 2026

Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Centinel Spine, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Cook Incorporated

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

One Step 10A in vitro diagnostic test

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

DFI Co., Ltd.

6 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Erbe Medical, LLC

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Intuitive Surgical, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Katalyst Surgical, LLC

11 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Medical Action Industries, Inc. 306

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medline Industries, LP

41 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Mint Medical GmbH

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Orthorebirth Co. Ltd.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Physio-Control, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Spacelabs Healthcare, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Ventec Life Systems, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

i-STAT EG7+ cartridge; List Number: 03P76-25;

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Abbott Point Of Care Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110;…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Advanced Bionics, LLC

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Becton Dickinson & Co.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

iLet Bionic Pancreas, REF: BB1001

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Beta Bionics, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Boston Scientific Corporation

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Clinical Innovations, LLC

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Depuy (ireland)

8 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Brand Name: Leksell Vantage Arc System REF: 1053958

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Elekta, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Healthmark Industries Co., Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Heraeus, PALAMIX uno. Material Number: 66057893.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Heraeus Medical GmbH (Dental Division)

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Hologic, Inc.

FDA (openFDA device enforcement)

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Related categories

RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.