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.

13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.

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)

Medical devices

Reported May 6, 2026

Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens…

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

Immuno-Mycologics, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X…

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

Medline Industries, LP

37 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial…

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

Medtronic, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY

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

Merit Medical Systems, Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

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

Milestone S.R.L.

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits…

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

North American Rescue LLC.

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.

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

Philips North America

18 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

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

Siemens Healthcare Diagnostics Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

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

Siemens Healthcare Diagnostics, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

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

Straumann USA LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2026

WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated…

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

Whill, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

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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.