Browse Device Recalls

797 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 797 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 797 FDA device recalls in TX.

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DateProductReasonClassFirm
Apr 6, 2020 SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - 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 CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - ... 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), 5CC. Product Number: 660-02-05, UDI: 813845021006... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
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 Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage:... Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc ... Class II Skeletal Kinetics, Llc
Apr 2, 2020 Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACC... In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Mo... Class II Abbott Laboratories
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 18, 2020 Frames Direct Prescription Spectacle Lenses included in the frame brands The firm has become aware through their optical laboratory supplier that prescription spectacle ... Class II Frames Direct
Feb 21, 2020 R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124;... Incorrect expiration date on introduction cannula packaging. Class II Epimed International
Feb 21, 2020 R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496;... Incorrect expiration date on introduction cannula packaging. Class II Epimed International
Feb 4, 2020 VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 81... False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output curren... Class II LivaNova USA 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.
Dec 4, 2019 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 1141... The stiffness of the soft end of the guidewire caused tissue perforation. Class I Argon Medical Devices, Inc
Dec 4, 2019 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114... The stiffness of the soft end of the guidewire caused tissue perforation. Class I Argon Medical Devices, Inc
Dec 2, 2019 BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial... Incorrect product labeling. Class II Argon Medical Devices, Inc
Nov 4, 2019 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: ... The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain th... Class II Trilliant Surgical, LLC
Oct 22, 2019 EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026... The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking d... Class II Encore Medical, LP
Oct 11, 2019 Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may ... Class II Stryker Communications
Oct 10, 2019 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Steri... Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL0... Class II Trilliant Surgical, LLC
Aug 22, 2019 VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal ne... Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-en... Class I LivaNova USA Inc
Aug 21, 2019 CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307. Reports received of the device fracturing during insertion. Class II CTL Medical Corporation
Aug 21, 2019 CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308. Reports received of the device fracturing during insertion. Class II CTL Medical Corporation
Aug 21, 2019 CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908. Reports received of the device fracturing during insertion. Class II CTL Medical Corporation
Aug 21, 2019 CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907. Reports received of the device fracturing during insertion. Class II CTL Medical Corporation
Aug 14, 2019 Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A Due to manufacturing processing error, wrench causing stripping when torqueing nuts. Class II New Standard Device Inc
Aug 13, 2019 VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1... Firm identified a subset of its generators that were sterilized one additional sterilization cycl... Class II LivaNova USA Inc
Aug 6, 2019 BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors... The device data being collected and transferred to the monitoring center may not be accurate due ... Class II Preventice Services, LLC
Aug 1, 2019 Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a componen... The mounts on the monitor may have an insufficient weld. Class II Stryker Communications
Jul 23, 2019 'n'-Hole Post which is a component of the Revolution External Fixation System... The threads on posts stripping out when tensioned during application process. Class II New Standard Device 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.