Browse Device Recalls

788 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 788 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 788 FDA device recalls in TX.

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Date	Product	Reason	Class	Firm
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
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

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.