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
Dec 2, 2020 Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per ... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per ... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per cas... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes p... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Nov 20, 2020 VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product... A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may... Class II Ortho-Clinical Diagnostics, Inc.
Nov 20, 2020 enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN ... A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may... Class II Ortho-Clinical Diagnostics, Inc.
Nov 19, 2020 CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Produ... The expiration date on labeling is incorrect. Class II Lidco Ltd
Nov 19, 2020 Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, ... Pumps manufactured with impellers from a subset of lots from a single supplier are failing to ini... Class I Heartware, Inc.
Nov 12, 2020 Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone ... The product is mislabeled. Class II Biocomposites, Ltd.
Nov 10, 2020 AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102... The products subject to this recall may contain obvious, incorrect pouch labels while the outer b... Class III Applied Medical Technology Inc
Nov 10, 2020 Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit ... Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting ... Class II Merit Medical Systems, Inc.
Nov 10, 2020 Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Ste... Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting ... Class II Merit Medical Systems, Inc.
Nov 10, 2020 Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Onl... Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting ... Class II Merit Medical Systems, Inc.
Oct 30, 2020 DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); ac... The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be misl... Class II Neocis, Inc.
Oct 23, 2020 Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, ... Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... Class II Medtronic Heart Valves Division
Oct 23, 2020 BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administ... Product shelf cartons incorrectly labeled as products intended for the Latin American market. Alt... Class II Becton Dickinson & Company
Oct 23, 2020 VGlove NITRILE *** Protect Your Life 100 Patient examination gloves Package labeled as nitrile gloves, contains latex gloves. Class II HUBO INTERNATIONAL INC
Oct 23, 2020 Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS... Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... Class II Medtronic Heart Valves Division
Oct 23, 2020 Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usag... The distal tip ring of the fully articulating catheter may become dislodged during the procedure. Class II Intuitive Surgical, Inc.
Oct 23, 2020 Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-... Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... Class II Medtronic Heart Valves Division
Oct 12, 2020 Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. ... Labeling error, incorrect expiration date. Class II ROi CPS LLC
Oct 9, 2020 Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling b... Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary c... Class III Talladium Inc
Oct 8, 2020 KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil... Class III Microbiologics Inc
Oct 6, 2020 Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium The product may be mislabeled. Class II Exactech, Inc.
Oct 6, 2020 Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium The product may be mislabeled. Class II Exactech, Inc.
Oct 6, 2020 Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box... Class III Hardy Diagnostics
Oct 1, 2020 Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ75... Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon siz... Class II Bard Peripheral Vascular Inc
Oct 1, 2020 EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: Thi... The use of deionized water rather than distilled water during the manufacturing process, may have... Class II Epitope Diagnostics, Inc.
Sep 30, 2020 XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Steri... Cervical Implants contain a label that incorrectly identifies the grade of titanium used. Class III XTANT Medical
Sep 26, 2020 AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 us... Mislabeling; It has been determined that some batteries were improperly labeled and may contain a... Class III Advanced Bionics, LLC
Sep 26, 2020 AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 us... Mislabeling; It has been determined that some batteries were improperly labeled and may contain a... Class III Advanced Bionics, LLC
Sep 21, 2020 DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Pr... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a v... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usag... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a v... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usag... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a v... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usa... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 18, 2020 OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur) Product may be mislabeled. Class II Merete Medical GmbH
Sep 18, 2020 OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails Product may be mislabeled. Class II Merete Medical GmbH
Sep 18, 2020 OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) Product may be mislabeled. Class II Merete Medical GmbH

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.