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 Apr 24, 2024

POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

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

Surgical Specialties

FDA (openFDA device enforcement)

Medical devices

Reported Apr 24, 2024

Neria Soft Infusion Set, Product Code 507302, intravascular administration set

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

Unomedical A/S

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP…

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

Baxter Healthcare Corporation

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both…

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

Boston Scientific Corporation

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1…

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

ConvaTec, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

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

Fresenius Kabi USA, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient…

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

Human Care Hc Sweden Ab

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098

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

Intuitive Surgical, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number…

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

MEDLINE INDUSTRIES, LP - Northfield

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for…

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

Microbiologics Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

Hemostasis Probe, Model: CD-B622LA

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

Olympus Corporation of the Americas

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to…

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

Philips North America

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2024

EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic…

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

Qiagen Sciences LLC

FDA (openFDA device enforcement)

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)

Free recall alerts

Get alerted about new Medical device recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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.