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 |
|---|---|---|---|---|
| Apr 2, 2020 | OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product U... | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... | Class II | Osteomed, LLC |
| Apr 2, 2020 | OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product ... | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... | Class II | Osteomed, LLC |
| Apr 2, 2020 | OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Pro... | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... | Class II | Osteomed, LLC |
| Apr 2, 2020 | OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usa... | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... | Class II | Osteomed, LLC |
| Apr 2, 2020 | OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product ... | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... | Class II | Osteomed, LLC |
| Mar 31, 2020 | Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guide... | There is a potential for thrombus formation on balloons prepped and staged in the vasculature for... | Class II | Spectranetics Corporation |
| Mar 27, 2020 | Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Ju... | A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration... | Class II | Stryker Sustainability Solutions |
| Mar 26, 2020 | VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 | Nonconforming product; length of the product measured shorter than the labeled length. | Class II | Medtronic Sofamor Danek USA Inc |
| Mar 23, 2020 | Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 11165... | The analyzer system may have an electrostatic discharge and sparking of the power supply provided... | Class II | Abbott Diagnostics Technologies AS |
| Mar 20, 2020 | Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm ... | The product has an incorrect reference value for cadmium and an incorrect expected range. | Class III | Utak Laboratories Inc |
| Mar 17, 2020 | RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single u... | RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was la... | Class II | Rayner Intraocular Lenses Limited |
| Mar 17, 2020 | PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Cat... | Iincorrectly packaged without the required lidocaine as labeled | Class II | Becton Dickinson & Company |
| Mar 10, 2020 | ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of wh... | Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ... | Class II | Radiometer Medical ApS |
| Mar 9, 2020 | Custom convenience kits containing Medline brand Sterile Pre-Saturated Povido... | Medline identified that there may be a potential for voids in the packaging seal and loss of ster... | Class II | Medline Industries Inc |
| Mar 6, 2020 | AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready... | The UDI on the device label indicates incorrect manufacturer. | Class III | Linet Americas |
| Mar 5, 2020 | GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to... | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner t... | Class II | Baxter Healthcare Corporation |
| Mar 5, 2020 | GEM Microvascular Anastomotic Coupler Devices s intended to be used in the an... | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner t... | Class II | Baxter Healthcare Corporation |
| Mar 5, 2020 | GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to ... | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner t... | Class II | Baxter Healthcare Corporation |
| Feb 28, 2020 | Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product U... | Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid inf... | Class II | Smiths Medical ASD Inc. |
| Feb 27, 2020 | CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue numbe... | The wall charger may not properly charge the infusion pump battery. | Class II | CME America LLC |
| Feb 13, 2020 | DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral ... | Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's ... | Class II | Merit Medical Systems, Inc. |
| Feb 13, 2020 | DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Verte... | Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's ... | Class II | Merit Medical Systems, Inc. |
| Feb 12, 2020 | KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 077... | KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) ... | Class II | Microbiologics Inc |
| Feb 12, 2020 | Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, conta... | KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) ... | Class II | Microbiologics Inc |
| Feb 11, 2020 | Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm | Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve... | Class II | MEDTRONIC ATS MEDICAL, INC. |
| Feb 10, 2020 | SPICE (JWH-018) CC443 | Corrections are being made to the device labeling regarding its intended use, to include a statem... | Class II | Carolina Liquid Chemistries Corp |
| Feb 3, 2020 | iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR ... | A limited number of tibial trays were labeled with an incorrect serial number and were delivered ... | Class II | Conformis, Inc. |
| Feb 3, 2020 | iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS ... | A limited number of tibial trays were labeled with an incorrect serial number and were delivered ... | Class II | Conformis, Inc. |
| Feb 3, 2020 | TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD... | Custom surgical kits contain a plate different than indicated by the package labeling. | Class II | Materialise N.V. |
| Feb 3, 2020 | ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4M... | The firm received reports of occurrences where the barcode reader misinterpreted the contents of... | Class II | Radiometer Medical ApS |
| Feb 3, 2020 | ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intende... | The firm received reports of occurrences where the barcode reader misinterpreted the contents of... | Class II | Radiometer Medical ApS |
| Feb 3, 2020 | TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 | Custom surgical kits contain a plate different than indicated by the package labeling. | Class II | Materialise N.V. |
| Jan 27, 2020 | Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices ar... | These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The uppe... | Class II | Exactech, Inc. |
| Jan 27, 2020 | fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans A... | FridaBaby has been made aware through customer reports that the product is being used outside of ... | Class II | Fridababy LLC |
| Jan 22, 2020 | Triton Canister System (finished part numbers FG 12009, for 3L canisters, and... | Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance.... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jan 20, 2020 | Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2... | Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling t... | Class II | Carolina Liquid Chemistries Corp |
| Jan 15, 2020 | Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for d... | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... | Class II | Cardinal Health 200, LLC |
| Jan 15, 2020 | Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usa... | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... | Class II | Cardinal Health 200, LLC |
| Jan 15, 2020 | BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Sept... | The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock pe... | Class II | Bard Peripheral Vascular Inc |
| Jan 15, 2020 | Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 1... | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... | Class II | Cardinal Health 200, LLC |
| Jan 15, 2020 | Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usag... | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... | Class II | Cardinal Health 200, LLC |
| Jan 14, 2020 | Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, ... | The bracket torque was mislabeled on the packaging. | Class II | Ormco/Sybronendo |
| Jan 3, 2020 | Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows:... | ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were s... | Class II | ROi CPS LLC |
| Dec 27, 2019 | WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222 | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both th... | Class II | Wright Medical Technology, Inc. |
| Dec 27, 2019 | WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220 | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both th... | Class II | Wright Medical Technology, Inc. |
| Dec 23, 2019 | Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00 | Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed ... | Class II | Zimmer Biomet, Inc. |
| Dec 20, 2019 | Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use... | A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK... | Class II | Custom Healthcare Systems, Inc. |
| Dec 17, 2019 | AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Prod... | A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with Inhib... | Class II | Boston Scientific Corporation |
| Dec 17, 2019 | Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This d... | The incorrect label was placed on both the primary and secondary package. | Class II | W L Gore & Associates, Inc. |
| Dec 17, 2019 | Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168... | Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or ... | Class II | Quest Medical, 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.