Browse Device Recalls
816 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 816 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 816 FDA device recalls in TX.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 10, 2020 | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N,... | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... | Class II | Argon Medical Devices, Inc |
| Dec 10, 2020 | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, ... | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... | Class II | Argon Medical Devices, Inc |
| Dec 10, 2020 | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S,... | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... | Class II | Argon Medical Devices, Inc |
| Dec 10, 2020 | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C,... | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... | Class II | Argon Medical Devices, Inc |
| Nov 23, 2020 | APEX Compounding System Control Panel Module, REF: 601238, Product Code AX100... | There is the potential for the compounding system to not immediately interrupt compounding and al... | Class II | B Braun Medical, Inc. |
| Nov 23, 2020 | APEX Compounding System Control Panel Module, REF: 601224, Product Code AX100... | There is the potential for the compounding system to not immediately interrupt compounding and al... | Class II | B Braun Medical, Inc. |
| Nov 23, 2020 | APEX Compounding System Control Panel Module, REF: 601237, Product Code AX100... | There is the potential for the compounding system to not immediately interrupt compounding and al... | Class II | B Braun Medical, Inc. |
| Nov 16, 2020 | Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Ce... | Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in ... | Class II | Galt Medical Corporation |
| Nov 12, 2020 | VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment... | During internal testing, it was found that upon a device reset, the Generator exhibits the incorr... | Class II | LivaNova USA Inc |
| Nov 9, 2020 | K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATE... | Due to complaints received associated with cracked/split test tube caps. | Class II | Helena Laboratories, Corp. |
| Oct 29, 2020 | PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Co... | There is a potential that catheters may have incorrectly marked balloon and arterial lines. Th... | Class II | Prytime Medical Devices, Inc. |
| Sep 28, 2020 | VNS Therapy¿ AspireSR¿ Generator | Due to an extra digit being inadvertently added to the serial number of a subset of implantable p... | Class II | LivaNova USA Inc |
| Sep 9, 2020 | EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Si... | Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the s... | Class II | Encore Medical, LP |
| Aug 31, 2020 | AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Nu... | Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery. | Class II | Encore Medical, LP |
| Aug 24, 2020 | Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXI... | The third-party brand latex micro surgical gloves packaged within specific custom packs may have ... | Class II | Alcon Research, LLC |
| Aug 17, 2020 | Speed Stitch Needle Cassette | Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result,... | Class II | ArthroCare Corporation |
| Aug 7, 2020 | RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00... | Product may be mislabeled with the size etched onto products differing from the size information ... | Class II | Encore Medical, LP |
| Aug 7, 2020 | RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044 | Product may be mislabeled with the size etched onto products differing from the size information ... | Class II | Encore Medical, LP |
| Aug 3, 2020 | DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contai... | There is a potential for the retaining pin of the tibial punch handle to become loose and fall ou... | Class II | Encore Medical, LP |
| 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 |
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.