Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
Jan 10, 2014 T:slim Insulin Delivery System Insulin Infusion Pump Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for... Class I Tandem Diabetes Care Inc
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... The tracheal tube can kink during patient use. Class I Teleflex Medical
Dec 16, 2013 Puritan Bennett 840 ventilator systems software part number 4-070212-85, revi... Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator syst... Class I Covidien
Dec 6, 2013 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catal... The housing to the Pump's driveline connector became partially or fully separated from the front ... Class I HeartWare Inc
Dec 5, 2013 Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto... CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will... Class I CareFusion 303, Inc.
Nov 25, 2013 Viscocel and Viscocel Plus. These products are intraocular fluid devices c... CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in ... Class I C.L.R. Medicals International, Inc.
Nov 18, 2013 FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 co... Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low bl... Class I Abbott Diabetes Care, Inc.
Nov 18, 2013 FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. ... Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low bl... Class I Abbott Diabetes Care, Inc.
Oct 31, 2013 Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions incl... Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Enc... Class I Hospira Inc.
Oct 31, 2013 Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infus... Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly... Class I Hospira Inc.
Oct 28, 2013 Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: ... Promotional materials for non-medical water filtration products were determined to promote claims... Class I Nephros Inc
Oct 28, 2013 Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ... Promotional materials for non-medical water filtration products were determined to promote claims... Class I Nephros Inc
Oct 28, 2013 1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros ... Promotional materials for non-medical water filtration products were determined to promote claims... Class I Nephros Inc
Oct 21, 2013 THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT19... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PR... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Med... Class I Medtronic Vascular
Oct 21, 2013 ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZR... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Att... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, T... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS19... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 17, 2013 CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation,... Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 a... Class I Del Mar Reynolds Medical, Ltd.
Oct 11, 2013 TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube o... Incorrect instructions for use (IFU). Class I Codman & Shurtleff, Inc.
Oct 11, 2013 TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes ... Incorrect instructions for use (IFU). Class I Codman & Shurtleff, Inc.
Oct 1, 2013 GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe S... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Oct 1, 2013 GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: T... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Oct 1, 2013 GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Sep 30, 2013 Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX0... Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because... Class I Bard Peripheral Vascular Inc
Sep 30, 2013 Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl I... Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one c... Class I Merit Medical Systems, Inc.
Sep 23, 2013 Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, st... The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sh... Class I Baylis Medical Corp *
Sep 19, 2013 Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology ... Atossa Genetics is recalling ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Te... Class I Atossa Genetics, Inc.
Sep 19, 2013 Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Dispos... GE Healthcare has recently become aware of a potential safety issue due to air leakage associated... Class I GE Healthcare, LLC
Sep 16, 2013 PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lowe... PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding ... Class I Pentax Medical Company
Sep 16, 2013 Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D,... Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformat... Class I Edwards Lifesciences, LLC
Sep 16, 2013 GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume ... GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance ... Class I GE Healthcare, LLC
Sep 5, 2013 Product Name: AVEA¿ Ventilator. All Models. The affected devices are clear... CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher ... Class I Carefusion 211 Inc dba Carefusion
Aug 28, 2013 GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Inte... GE Healthcare has recently become aware of a potential safety issue involving unresponsive button... Class I GE Healthcare, LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.