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 |
|---|---|---|---|---|
| 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 |
| Sep 18, 2020 | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia) | Product may be mislabeled. | Class II | Merete Medical GmbH |
| Sep 17, 2020 | LOM Disposable Surgical Gowns/Medical Gowns, Single-Use | Medical gowns distributed to customers did not include appropriate labeling, and some gowns may n... | Class II | THREAD COUNSEL INC DBA LAWS OF MOTION |
| Sep 14, 2020 | Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the p... | Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to... | Class II | Becton Dickinson & Company |
| Sep 14, 2020 | Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the pe... | Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to... | Class II | Becton Dickinson & Company |
| Sep 14, 2020 | MR Coils The MR Coil is intended to be used in conjunction with a Magnetic... | The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protect... | Class III | Invivo Corporation |
| Sep 9, 2020 | VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - ... | Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. T... | Class II | Ethicon, Inc. |
| Sep 8, 2020 | MediCult Vitrification Cooling Media, Model Number 12284001F | There is a discrepancy between the printing on the Product Tyvek label of the individual componen... | Class II | CooperSurgical, Inc. |
| Aug 31, 2020 | AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Nu... | Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery. | Class II | Encore Medical, LP |
| Aug 28, 2020 | Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to... | Label has the incorrect size for the tracheotomy tube. | Class II | Smiths Medical ASD Inc. |
| Aug 26, 2020 | Pacific Xtreme (PTCA Balloon Dilation Catheter) | Labeling discrepancy for the Rated Burst Pressure (RBP) value. | Class II | ev3 Inc. |
| Aug 24, 2020 | Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICA... | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contain... | Class II | Irvine Biomedical Inc, a St. Jude Medical Co. |
| Aug 24, 2020 | EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indic... | Multiple or incorrect expiration dates were provided on the affected designation labels. | Class II | Smith & Nephew, Inc. |
| Aug 24, 2020 | Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICA... | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contain... | Class II | Irvine Biomedical Inc, a St. Jude Medical Co. |
| Aug 21, 2020 | 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged ... | Lack of sterility assurance of the 30-0171 | Class II | North American Rescue LLC. |
| Aug 18, 2020 | CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "A... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AM... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
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.