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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.