Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 12, 2018 | Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee syst... | Firm became aware that the specific product/lot combinations referenced above may contain the inc... | Class II | Howmedica Osteonics Corp. |
| Jan 11, 2018 | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, ... | Sterility failure found in one of the units in the lot. | Class II | Ellex iScience, Inc. |
| Jan 10, 2018 | PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Si... | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were label... | Class II | Ethicon, Inc. |
| Jan 10, 2018 | PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Si... | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were label... | Class II | Ethicon, Inc. |
| Jan 10, 2018 | PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Si... | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were label... | Class II | Ethicon, Inc. |
| Jan 9, 2018 | RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Us... | Product is labeled with "CE", but is not yet approved in the European Union. | Class III | Riverpoint Medical, LLC |
| Jan 4, 2018 | BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*... | Increase of events affecting performance regarding pump clogging and displacement of the color-co... | Class II | bioMerieux, Inc. |
| Jan 4, 2018 | Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 ... | The power supply unit may be damaged and may fail to start up when the power plug is inserted int... | Class II | Toshiba American Medical Systems Inc |
| Jan 4, 2018 | BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) ... | Increase of events affecting performance regarding pump clogging and displacement of the color-co... | Class II | bioMerieux, Inc. |
| Jan 3, 2018 | Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UD... | Two lots of hip implants are mislabeled. | Class II | Zimmer Biomet, Inc. |
| Jan 3, 2018 | HEMASHIELD Knitted Double Velour Cardiovascular Fabric | A probable mislabeling of the product: a different-sized product is referenced on the product pac... | Class II | GETINGE US SALES LLC |
| Dec 20, 2017 | The humeral stems trials are packaged in a kit for Titan Modular Shoulder Sys... | Incidents of stem trial breakage were reported to the firm suggesting that these fractures all oc... | Class II | Integra LifeSciences Corp. |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Label... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Label... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Label... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the ... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray wit... | DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tr... | Class II | DeRoyal Industries Inc |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as ... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. V... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the followi... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the fo... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, S... | The product is labeled with the incorrect expiration date. | Class III | LivaNova USA |
| Dec 19, 2017 | PerkinElmer 226 Sample Collection Device | PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the p... | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 18, 2017 | Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size:... | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | COACH¿ Self-Adhering Sports Wrap (size: 3in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size:... | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | COACH¿ Self-Adhering Sports Wrap (size: 2in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 15, 2017 | Alere iScreen Dx Urine Drug Screen Card | The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Anti... | Class III | Ameditech Inc |
| Dec 14, 2017 | Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded... | Torn sheath liner material was detected at the proximal end of the device during internal product... | Class II | Kalila Medical |
| Dec 14, 2017 | Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is w... | Torn sheath liner material was detected at the proximal end of the device during internal product... | Class II | Kalila Medical |
| Dec 11, 2017 | smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating... | Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-... | Class II | Smith & Nephew, Inc. |
| Dec 11, 2017 | smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating... | Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-... | Class II | Smith & Nephew, Inc. |
| Dec 8, 2017 | ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the A... | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Dec 8, 2017 | Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revisi... | Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. ... | Class II | Zimmer Biomet, Inc. |
| Dec 8, 2017 | ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARC... | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Dec 8, 2017 | Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revisi... | Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. ... | Class II | Zimmer Biomet, Inc. |
| Dec 8, 2017 | ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARC... | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Dec 7, 2017 | 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887... | One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated scr... | Class II | Zimmer Biomet, Inc. |
| Dec 7, 2017 | Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on... | Some of the cards show occasional shorter clot times than the expected variation resulting in a p... | Class II | Helena Laboratories, Corp. |
| Dec 4, 2017 | Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM... | Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kit... | Class II | Smiths Medical ASD Inc. |
| Dec 4, 2017 | Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461;... | The Oncomine Dx Target Test may report erroneous results when used off-label for samples other th... | Class II | Life Technologies Corporation |
| Dec 4, 2017 | PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM... | Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kit... | Class II | Smiths Medical ASD Inc. |
| Dec 1, 2017 | 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL ... | 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves. | Class II | Stryker Sustainability Solutions |
| Dec 1, 2017 | RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplast... | Incorrect product and/or label. Sizing is labeled incorrectly. | Class II | Mako Surgical Corporation |
| Nov 29, 2017 | Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10. | Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvert... | Class II | Zimmer Dental Inc |
| Nov 29, 2017 | Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10. | Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvert... | Class II | Zimmer Dental Inc |
| Nov 28, 2017 | The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemen... | The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was i... | Class II | DePuy Orthopaedics, Inc. |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF T... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
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.