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.
13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Jun 9, 2021
REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Meta C.G.M. Spa
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 9, 2021
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Multitom RAX with software version VF10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Signature Orthopedics Pty Limited
FDA (openFDA device enforcement)
Reported Jun 9, 2021
The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.The Biomed Guys
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vygon U.S.A.
FDA (openFDA device enforcement)
Reported Jun 9, 2021
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zavation
70 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 2, 2021
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Jun 2, 2021
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Jun 2, 2021
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
FDA (openFDA device enforcement)
Reported Jun 2, 2021
Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dentech Corp.
FDA (openFDA device enforcement)
Reported Jun 2, 2021
MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.James Leckey Design Ltd.
FDA (openFDA device enforcement)
Reported Jun 2, 2021
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare Procera LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 2, 2021
VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jun 2, 2021
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pentax
FDA (openFDA device enforcement)
Reported Jun 2, 2021
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Jun 2, 2021
BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Respironics, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 2, 2021
PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Radiometer Medical ApS
FDA (openFDA device enforcement)
Reported Jun 2, 2021
IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
FDA (openFDA device enforcement)
Reported Jun 2, 2021
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jun 2, 2021
GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Welch Allyn Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 26, 2021
REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Access Systems Inc.
17 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.