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 |
|---|---|---|---|---|
| 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 22, 2021 | RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7,... | For some LINAC types, merging clinical beams with beams of approximate dose may lead to the appro... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 22, 2021 | EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter,... | It has been identified that the catheter size on the packaging labeling does not correspond to th... | Class II | EPIX THERAPEUTICS, INC |
| Feb 22, 2021 | EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, ... | It has been identified that the catheter size on the packaging labeling does not correspond to th... | Class II | EPIX THERAPEUTICS, INC |
| Feb 22, 2021 | EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.... | It has been identified that the catheter size on the packaging labeling does not correspond to th... | Class II | EPIX THERAPEUTICS, INC |
| Feb 22, 2021 | EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve,... | It has been identified that the catheter size on the packaging labeling does not correspond to th... | Class II | EPIX THERAPEUTICS, INC |
| Feb 22, 2021 | EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve... | It has been identified that the catheter size on the packaging labeling does not correspond to th... | Class II | EPIX THERAPEUTICS, INC |
| Feb 22, 2021 | EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.... | It has been identified that the catheter size on the packaging labeling does not correspond to th... | Class II | EPIX THERAPEUTICS, INC |
| Feb 16, 2021 | EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - ... | Contact lenses may be mislabeled with the incorrect lens power. | Class II | Clerio Vision |
| Feb 11, 2021 | JUDKINS PACK | Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) ... | Class II | Cardinal Health 200, LLC |
| 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. |
| Feb 4, 2021 | Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz... | The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) int... | Class II | Siemens Medical Solutions USA, 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 25, 2021 | Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Aceta... | The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... | Class II | Corin Ltd |
| Jan 25, 2021 | Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acet... | The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... | Class II | Corin Ltd |
| Jan 21, 2021 | Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/S... | The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), in... | Class II | CooperSurgical, Inc. |
| Jan 21, 2021 | Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referr... | The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does... | Class II | G & H Wire Company |
| Jan 19, 2021 | HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consis... | The labeled needle tip curvature of specific lots of transseptal needles may not match the actual... | Class II | Merit Medical Systems, Inc. |
| Jan 19, 2021 | Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consi... | The labeled needle tip curvature of specific lots of transseptal needles may not match the actual... | Class II | Merit Medical Systems, Inc. |
| Jan 19, 2021 | Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthr... | Non-sterile product was shipped to customers labelled as sterile. | Class II | ReNovo, Inc. |
| Jan 15, 2021 | Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is inten... | Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Sh... | Class II | Biomet, Inc. |
| Jan 14, 2021 | BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm R... | Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy ne... | Class II | Bard Peripheral Vascular Inc |
| Jan 13, 2021 | Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - ... | incorrect device is contained in the package. The packaging label indicates that the device is fo... | Class II | Covidien Llc |
| Jan 12, 2021 | Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 ... | Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 2... | Class II | Shent USA, Inc. |
| Jan 12, 2021 | Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog ... | Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 2... | Class II | Shent USA, Inc. |
| Jan 7, 2021 | BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In... | Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MA... | Class II | Becton Dickinson & Co. |
| Dec 30, 2020 | ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on th... | The Quality Control (QC) card has a label error for the standard deviation (SD) values for one ou... | Class II | Beckman Coulter 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 22, 2020 | Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2... | Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a... | Class II | Cytocell Ltd. |
| Dec 21, 2020 | PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No.... | Medical device non-conformance to electrical safety standard (IEC 60601-1). | Class II | Nihon Kohden America Inc |
| Dec 18, 2020 | AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, ... | Labeling update; To reduce the risk of false positive/false negative results the IFU for the adap... | Class II | Ansh Labs, LLC |
| Dec 17, 2020 | Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concent... | Bottles Missing Product Label | Class II | Fresenius Medical Care Holdings, 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 |
| Dec 14, 2020 | Neuroreader Medical Image Processing Software - Product Usage: intended to au... | The Neuroreader has been distributed with a reference normative database that is different from ... | Class II | Brainreader ApS |
| Dec 14, 2020 | Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use... | Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ... | Class II | Integra LifeSciences Corp. |
| Dec 14, 2020 | Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: u... | Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ... | Class II | Integra LifeSciences Corp. |
| Dec 10, 2020 | Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334... | One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -... | Class II | Clerio Vision |
| Dec 8, 2020 | smiths medical portex Loss of Resistance Device, REF 100/398/000 | The labeling was missing information on sterilization and prohibition of reuse. | Class II | Smiths Medical ASD Inc. |
| Dec 5, 2020 | visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitativ... | Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the pr... | Class II | VISBY MEDICAL INC |
| Dec 2, 2020 | Vis-U-All High Temperature Tubing 4"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 steam ... | Class II | Steris Corporation |
| Dec 2, 2020 | Vis-U-All High Temperature Tubing 3"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 | Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)0761236705392... | Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date sh... | Class II | Medela AG Medical Technology |
| Dec 2, 2020 | Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 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 7.5"x13" 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 8"x16" Self Seal Pouch 200 pouches per box; 4 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 5"x15" Self Seal Pouch 200 pouches per box; 4 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 4"x11" Self Seal Pouch 200 pouches per box; 4 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 5.5"x10" 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 Temperature Tubing 6"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 |
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.