Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Feb 5, 2018 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotati... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Cla... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connect... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 2, 2018 Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-p... The pouch integrity of the sterile product can't be assured without a visual examination due to p... Class II Shippert Medical Technologies
Feb 2, 2018 Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one... Class II Shippert Medical Technologies
Feb 2, 2018 Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature cer... This recall has been identified due to the batch being mislabeled, with the packaged component's... Class II Signature Orthopedics Pty Limited
Feb 2, 2018 Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patie... The pouch integrity of the sterile product can't be assured without a visual examination due to p... Class II Shippert Medical Technologies
Feb 2, 2018 Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-p... The pouch integrity of the sterile product can't be assured without a visual examination due to p... Class II Shippert Medical Technologies
Feb 2, 2018 Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-p... The pouch integrity of the sterile product can't be assured without a visual examination due to p... Class II Shippert Medical Technologies
Feb 2, 2018 Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one... Class II Shippert Medical Technologies
Feb 2, 2018 Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, on... The pouch integrity of the sterile product can't be assured without a visual examination due to p... Class II Shippert Medical Technologies
Jan 31, 2018 FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankl... Class II 3M Company - Health Care Business
Jan 31, 2018 ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankl... Class II 3M Company - Health Care Business
Jan 30, 2018 Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The kn... Customers may receive the incorrect size implant from what is labeled on the box. Class II Howmedica Osteonics Corp.
Jan 29, 2018 AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytomet... The device may process the same sample with two different sample IDs and sample information while... Class II Beckman Coulter Inc.
Jan 23, 2018 Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0m... InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being... Class II Implant Direct Sybron Manufacturing, LLC
Jan 22, 2018 Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A ... DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valv... Class II DeRoyal Industries Inc
Jan 22, 2018 Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors... The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated... Class II Valeris Medical, LLC
Jan 19, 2018 InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC Insulin syringe retail packages incorrectly labeled as "Short Needle". Class II Allison Medical, Inc.
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

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.