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 May 31, 2023
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported May 31, 2023
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Headquarters Cambridge
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 31, 2023
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207…
High riskUsing this product could cause serious injury, illness or death — stop using it now.SD Biosensor, Inc.
FDA (openFDA device enforcement)
Reported May 31, 2023
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 31, 2023
Luminos Agile Max (VE10, VF10, VF11)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 31, 2023
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 24, 2023
3M Attest Steam Chemical Integrators, REF 1243A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Company - Health Care Business
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 24, 2023
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported May 24, 2023
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Access Vascular, Inc.
FDA (openFDA device enforcement)
Reported May 24, 2023
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 24, 2023
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 24, 2023
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 24, 2023
Seattle PAP Plus, MP02260
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
21 more products in this recall
FDA (openFDA device enforcement)
Reported May 24, 2023
Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dynasthetics LLC
FDA (openFDA device enforcement)
Reported May 24, 2023
Fisher Wallace Stimulator Models FW-100 and FW-200
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fisher Wallace Laboratories Inc.
FDA (openFDA device enforcement)
Reported May 24, 2023
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One North America, Inc.
FDA (openFDA device enforcement)
Reported May 24, 2023
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hiossen Inc.
FDA (openFDA device enforcement)
Reported May 24, 2023
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 24, 2023
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.IMMUNDIAGNOSTIK, Inc.
FDA (openFDA device enforcement)
Reported May 24, 2023
Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported May 24, 2023
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
4 more products in this recall
FDA (openFDA device enforcement)
Reported May 24, 2023
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 24, 2023
Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
FDA (openFDA device enforcement)
Reported May 24, 2023
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
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.