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 Sep 2, 2026Updated Sep 27, 2026
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConMed Corporation
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Renal Therapies Group, LLC
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
healthmark ProChek-II, Model Number PT-313, PT-201-12
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Healthmark Industries Co., Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Henry Schein Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hollister Ulc
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.IMRIS Imaging Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 26, 2026
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
18 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Midmark Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting &…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Healthcare (Suzhou) Co., Ltd.
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number…
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 Aug 26, 2026Updated Sep 7, 2026
Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arrowhead DE LLC
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Bard Access Systems, Inc.
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number…
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 Aug 26, 2026Updated Sep 7, 2026
BMC/REACTHEALTH Luna G3 APAP REF LG 3600
High riskUsing this product could cause serious injury, illness or death — stop using it now.BMC Medical Co., Ltd.
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, Inc.
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.