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 Apr 17, 2024

RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including…

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

Raysearch Laboratories Ab

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

Chromophare Surgical Light System , REF CH00000001

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

Stryker Communications

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers:…

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

Synovo Production

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2…

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

3M Company - Health Care Business

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

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

Abbott GmbH

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.

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

Abbott Laboratories

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console,…

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

Agfa N.V.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention…

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

Baxter Healthcare Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene…

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 Apr 10, 2024

Ureteral dilator, REF RBD014

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

Coloplast Manufacturing US, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT

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

Covidien, LP

8 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee…

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

DePuy Orthopaedics, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number…

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

Exactech, Inc.

23 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only

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

Karl Storz Endoscopy

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for…

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

Life Technologies Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

Centurion STERILE TRACH BRUSH, Product Code 6225ST

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

MEDLINE INDUSTRIES, LP - Northfield

29 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

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

Navinetics Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)

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

O&m Halyard, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

Mojo Full Face with Headgear, All Sizes

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

SleepNet Corporation

6 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

Trumpet, Needle Guide, Cat# TMS-200

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

Technicality Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312…

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

Terumo Cardiovascular Systems Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

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

Wright Medical Technology, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2024

X-Guide Handpiece Adaptor Sleeve 1, Model P010701

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

X-NAV Technologies, LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 3, 2024

SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products:…

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

Alcon Research, LLC

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.