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.
Reported Jul 27, 2022
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Jul 27, 2022
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
FDA (openFDA device enforcement)
Reported Jul 27, 2022
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
FDA (openFDA device enforcement)
Reported Jul 27, 2022
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Hobbs Medical Polypectomy Snare, Catalog No. 7202
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hobbs Medical, Inc.
FDA (openFDA device enforcement)
Reported Jul 27, 2022
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LumiraDx
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.R & D Systems, Inc.
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Randox Laboratories Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
RayStation 9B SP1. For radiation treatment planning.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
FDA (openFDA device enforcement)
Reported Jul 27, 2022
SX-One MicroKnife
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sonex Health LLC
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Stryker Instruments Div.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
FDA (openFDA device enforcement)
Reported Jul 27, 2022
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Surgical Innovations Ltd.
FDA (openFDA device enforcement)
Reported Jul 27, 2022
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Synapse Biomedical Inc.
FDA (openFDA device enforcement)
Reported Jul 27, 2022
X80 RADiant Photoelectric Therapy System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Xstrahl Limited
FDA (openFDA device enforcement)
Reported Jul 20, 2022
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Agilent Technologies, Inc.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research, LLC
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Breas Medical, Inc.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
FDA (openFDA device enforcement)
Reported Jul 20, 2022
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cordis US Corp.
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.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.
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.