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
Jun 19, 2020 EMPOWR Partial Knee Peg Drill; Model: 800-06-008. There have been issues experienced with the peg preparation steps, specifically drilling of the F... Class II Encore Medical, LP
Jun 19, 2020 EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007. There have been issues experienced with the peg preparation steps, specifically drilling of the F... Class II Encore Medical, LP
Jun 19, 2020 ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. ... Sterile introducer sheath set manufactured under one lot with different expiration dates. Class II Argon Medical Devices, Inc
Jun 15, 2020 Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Cultu... An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negat... Class II Luminex Corporation
Jun 15, 2020 Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Cultur... An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negat... Class II Luminex Corporation
Jun 8, 2020 ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERIC... The device may power off without notification to the user resulting in a stoppage of negative pre... Class II KCI USA, INC.
Jun 8, 2020 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External P... 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The incr... Class II New Standard Device Inc
May 15, 2020 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
May 15, 2020 PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usa... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
May 15, 2020 PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Us... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
May 15, 2020 PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intende... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
May 15, 2020 PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usa... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
May 15, 2020 PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intende... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
May 15, 2020 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
Apr 26, 2020 Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 65550... Tungsten coils of the guidewire included in the introducer kit were detaching. Class II Argon Medical Devices, Inc
Apr 17, 2020 Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYL... Incorrect IOL diopter Class II Alcon Research LLC
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 008863... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 0088633... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UD... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 6, 2020 SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - Prod... 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 FORM (MX), 5CC. Product Number: 660-01-05, UDI: 81384502102... 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 FORM (MX), 10CC. Product Number: 660-01-10, UDI: 8138450210... 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, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 81384502... 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 IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Us... 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 IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is... 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, INJECT FORMULA. Product Number: 390-2005, UDI: 81384502005... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - 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 SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - 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 OSTEOVATION, 3CC, IMPACT FORMULA. Product Number: 390-2103, UDI: 81384502007... 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, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - P... 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, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - 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 CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Produ... 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, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 -... 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, SMALL. Product Number: C07A, UDI: 813845020504 -... 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, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351... 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 C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product U... 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 C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usa... 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 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 81384502000... 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 C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product U... 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, 10CC, INJECT FORMULA. Product Number: 390-2010, 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 SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UD... 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), 5CC. Product Number: CMMP-IM05, UDI: 813845020689... 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 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Pr... 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 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Pr... 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 5CC. Product Number: 390-6001, UDI: 813845021082 - Product U... 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 IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number... 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, 10CC, Product Number: C-FLOW10CC-CAN, 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 SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Produ... 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, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - 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 CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc

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.