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 2, 2024
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Spine
FDA (openFDA device enforcement)
Reported Oct 2, 2024
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.T.G. Eakin Limited
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.TMJ Solutions Inc.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Corp. Hq.)
FDA (openFDA device enforcement)
Reported Oct 2, 2024
GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wipro GE Healthcare Private Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose…
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)
Reported Sep 25, 2024
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Btt Health GmbH
FDA (openFDA device enforcement)
Reported Sep 25, 2024
BiomarC EX Fiducial Marker System, Catalog Number 040165
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Carbon Medical Technologies, Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cypress Medical Products LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
ViewPoint; system, imaging processing, radiological
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
FDA (openFDA device enforcement)
Reported Sep 25, 2024
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Innovasis, Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mazor Robotics Ltd.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Sep 25, 2024
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Sep 25, 2024
HAWK Warming Grid, Item Number: 59-300
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Safeguard US Operating LLC
2 more products 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.