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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 Aug 19, 2026Updated Aug 25, 2026

Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator ,…

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

Galt Medical Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Aug 19, 2026Updated Aug 25, 2026

Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4

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

Medline Industries, LP

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 19, 2026Updated Aug 25, 2026

BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in…

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

Microvention Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Aug 19, 2026Updated Aug 25, 2026

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

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

OBP Medical Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Aug 19, 2026Updated Sep 4, 2026

Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional…

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

Philips Medical Systems Nederland B.v.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 19, 2026Updated Aug 25, 2026

Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

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

Remel Europe Ltd.

FDA (openFDA device enforcement)

Medical devices

Reported Aug 19, 2026Updated Aug 25, 2026

Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product…

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

Spacelabs Healthcare, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Aug 19, 2026Updated Aug 25, 2026

Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule…

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

Spectra Medical Devices, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Aug 19, 2026Updated Aug 25, 2026

GM Helix Implant, Endosseous Dental Implant Article No. 109.984

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

Straumann USA LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 19, 2026Updated Aug 25, 2026

GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to…

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

Terumo Medical Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Aug 19, 2026Updated Aug 25, 2026

navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material…

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

Ventana Medical Systems, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Aug 19, 2026Updated Aug 25, 2026

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to…

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

W L Gore & Associates, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 19, 2026Updated Aug 25, 2026

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

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

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA (openFDA device enforcement)

Medical devices

Reported Aug 12, 2026

5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

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

Aniara Diagnostica LLC

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 12, 2026

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK…

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

AVID Medical, Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 12, 2026

REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager…

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

Beckman Coulter Biomedical GmbH

FDA (openFDA device enforcement)

Medical devices

Reported Aug 12, 2026

REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: -…

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)

Medical devices

Reported Aug 12, 2026

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a…

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

Biofire Defense

FDA (openFDA device enforcement)

Medical devices

Reported Aug 12, 2026

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade…

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

Biomet, Inc.

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 12, 2026

Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20;…

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

Boston Scientific Corporation

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 12, 2026

INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70,…

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

Boston Scientific Neuromodulation Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Aug 12, 2026

Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP…

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

Contego Medical, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Aug 12, 2026

Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3…

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

Copan WASP

FDA (openFDA device enforcement)

Medical devices

Reported Aug 12, 2026

Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF

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

Freudenberg Medical, LLC

1 more product 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.