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.
Reported Oct 14, 2026Updated Oct 20, 2026
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Alphenix INFX-8000C/B5
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DRG International, Inc.
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GRI Medical & Electronic Technology Co., Ltd.
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intellijoint Surgical, Inc.
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Glypto Device, Glypto Cryo Machine;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Limitless Cryo Spa LLC
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medical Action Industries, Inc. 306
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Nov 2, 2026
Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Mindray DS USA, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nihon Kohden America LLC
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Onkos Surgical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.QUANTUM OPS Inc.
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Safeguard US Operating LLC
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
FDA (openFDA device enforcement)
Reported Oct 7, 2026Updated Oct 13, 2026
McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alere San Diego, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 7, 2026Updated Oct 13, 2026
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 7, 2026Updated Oct 13, 2026
Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Nitrile Operations LLC
FDA (openFDA device enforcement)
Reported Oct 7, 2026Updated Oct 13, 2026
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ASP Global, LLC.
1 more product 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.
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.