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 |
|---|---|---|---|---|
| Apr 6, 2020 | ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Pro... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 81384502101... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 -... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 81384502069... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product ... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 81384502008... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 8138450200... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 81384502034... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 ... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 81384502... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 3, 2020 | Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medulla... | The lot number on the pediatric orthopedic implant driver instrument handle does not match the lo... | Class III | Pega Medical Inc. |
| Apr 2, 2020 | OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - 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 IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - 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 | OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - 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 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - 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 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Produc... | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... | Class II | Osteomed, LLC |
| Apr 2, 2020 | OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Produc... | 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 INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Us... | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... | Class II | Osteomed, LLC |
| 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 |
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.