Browse Device Recalls
1,023 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,023 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 1,023 FDA device recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 12, 2021 | Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower than expected or out o... | Class III | Stanbio Laboratory, LP |
| Jul 12, 2021 | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower than expected or out o... | Class III | Stanbio Laboratory, LP |
| Jul 12, 2021 | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic rea... | Deterioration in the stability of the reagents which has resulted in lower than expected or out o... | Class III | Stanbio Laboratory, LP |
| Jul 12, 2021 | Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vi... | Deterioration in the stability of the reagents which has resulted in lower than expected or out o... | Class III | Stanbio Laboratory, LP |
| Jul 1, 2021 | GlideScope Go Monitors | Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into ... | Class III | Verathon, Inc. |
| May 27, 2021 | 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Tele... | Telepack may not power on when using the 3AA battery cradle. | Class III | Mindray DS USA, Inc. dba Mindray North America |
| Apr 30, 2021 | ACE Control Set - IVD Control set for the quantitative determination of Angio... | Claim for stability after reconstitution from lyophilized to liquid form does not meet the requir... | Class III | Sentinel CH SpA |
| Apr 21, 2021 | VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling which has some differ... | Class III | MICROVENTION INC. |
| Apr 21, 2021 | VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling which has some differ... | Class III | MICROVENTION INC. |
| Apr 21, 2021 | VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling which has some differ... | Class III | MICROVENTION INC. |
| Mar 23, 2021 | VenaSeal Closure System | Firm received increased number of reports that VenaSeal dispensing systems are not effectively ad... | Class III | Medtronic Inc. |
| Mar 22, 2021 | Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aor... | There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m... | Class III | Datascope Corp. |
| Mar 22, 2021 | Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aor... | There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m... | Class III | Datascope Corp. |
| Mar 16, 2021 | EXALT Controller - Product Usage: intended for use with a Boston Scientific e... | May have been programmed with a less than optimal brightness setting resulting in a darker than ... | Class III | Boston Scientific Corporation |
| Feb 24, 2021 | KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged... | Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. | Class III | Microbiologics Inc |
| Feb 24, 2021 | KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0... | Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. | Class III | Microbiologics Inc |
| Feb 5, 2021 | Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination ... | Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labelin... | Class III | OraSure Technologies, Inc. |
| Jan 28, 2021 | Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve ba... | It was identified that tissue culture bags were incorrectly labeled as free of phthalates. | Class III | OriGen Biomedical, Inc. |
| Jan 15, 2021 | S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended... | Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O30300... | Class III | Medline Industries Inc |
| Jan 5, 2021 | HAMILTON-H900 Humidifier, Models: 950001, 950004 | When starting a humidifier, intended for respiratory gas conditioning during invasive and noninva... | Class III | Hamilton Medical AG |
| Jan 5, 2021 | Nucleic acid-based in vitro diagnostic devices for the detection of 2019-nove... | Users cannot complete testing due to a sign-error in the software component that controls the fil... | Class III | Biomeme, Inc. |
| Dec 22, 2020 | Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-... | FUJIFILM has become aware that incorrect concentration values were printed on the bottle label fo... | Class III | Fujifilm Medical Systems U.S.A., Inc. |
| Dec 16, 2020 | KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affecte... | The expiration date on the label of one component (negative control 0243U) in the set lot is inco... | Class III | Microbiologics Inc |
| 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 |
| Oct 16, 2020 | VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use... | Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verif... | Class III | Ortho Clinical Diagnostics Inc |
| 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 7, 2020 | Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid ... | Potential for cleaning solution intrusion into endoscope | Class III | Steris Corporation |
| 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 |
| 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 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 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 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 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 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 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 7, 2020 | Neoprobe GDS Control Unit, Model Number NPCU3 | It was discovered during a documentation review that China has the software version as v5.01 appr... | Class III | Devicor Medical Products Inc |
| Aug 27, 2020 | Albumin Gen.2, Catalog 05166861190 | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for... | Class III | Roche Diagnostics Operations, 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.