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 Apr 30, 2025
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Conavi Medical Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edge Biologicals Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Globus Medical, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ihb Operations B.v.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Apr 30, 2025
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Micro-X Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Radiometer Medical ApS
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remote Diagnostic Technologies Ltd.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Straumann USA LLC
FDA (openFDA device enforcement)
Reported Apr 30, 2025
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Diagnostics Scarborough, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Avanos Medical, Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Bard Access Systems, Inc.
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Welch Allyn Connex Vital Signs Monitor (CVSM):
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
9 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
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.