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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.