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