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 |
|---|---|---|---|---|
| Feb 27, 2018 | SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation a... | Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended... | Class III | Helena Laboratories, Corp. |
| Feb 23, 2018 | ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002 | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) w... | Class II | Orthofix, Inc |
| Feb 23, 2018 | ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003 | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) w... | Class II | Orthofix, Inc |
| Feb 13, 2018 | RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (... | All patient serum samples yield a weakly positive test result. | Class II | Stanbio Laboratory, LP |
| Feb 8, 2018 | Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The... | The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outl... | Class II | Stanbio Laboratory, LP |
| Jan 30, 2018 | AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 8... | Broken or missing screws and retaining clips. This may be due to screw tolerance and material st... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000... | The device could have a missing spanner nut and snap ring which could potentially result in the e... | Class II | Stryker Communications |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 26, 2018 | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a componen... | The mounts on the monitor may have an insufficient (missing or incomplete) weld. | Class II | Stryker Communications |
| Jan 24, 2018 | VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 | Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 program... | Class II | LivaNova USA Inc |
| Jan 12, 2018 | Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a c... | Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+... | Class II | Alcon Research, LTD. |
| Jan 12, 2018 | Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a c... | Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+... | Class II | Alcon Research, LTD. |
| Dec 28, 2017 | NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile | Potential for stylet to protrude from the distal end of the catheter | Class II | Epimed International |
| Dec 28, 2017 | NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile | Potential for stylet to protrude from the distal end of the catheter | Class II | Epimed International |
| Dec 12, 2017 | EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Q... | The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla... | Class II | Encore Medical, Lp |
| Dec 12, 2017 | EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE,... | The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla... | Class II | Encore Medical, Lp |
| Dec 12, 2017 | DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qt... | The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla... | Class II | Encore Medical, Lp |
| Dec 12, 2017 | EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Q... | The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla... | Class II | Encore Medical, Lp |
| Dec 8, 2017 | ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the A... | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Dec 8, 2017 | ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARC... | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Dec 8, 2017 | ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARC... | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Dec 7, 2017 | Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on... | Some of the cards show occasional shorter clot times than the expected variation resulting in a p... | Class II | Helena Laboratories, Corp. |
| Dec 2, 2017 | VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Us... | Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 ... | Class II | Cyberonics, Inc |
| Nov 22, 2017 | Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap... | Component of the Lap-Band system was missing from the package | Class II | Apollo Endosurgery Inc |
| Nov 13, 2017 | VNS Therapy Programmer, Model 3000, v1.0 System | Certain Model 3000 programming events can result in miscalculation of parameters stored in the Mo... | Class II | Cyberonics, Inc |
| Sep 29, 2017 | Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemis... | The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility... | Class II | Abbott Laboratories, Inc |
| Sep 29, 2017 | ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITE... | The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility... | Class II | Abbott Laboratories, Inc |
| Sep 15, 2017 | EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERIL... | It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. | Class II | Encore Medical, Lp |
| Sep 15, 2017 | EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE ... | It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. | Class II | Encore Medical, Lp |
| Sep 12, 2017 | Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable... | Analysis of the difference between the actual device longevity and the battery indicator status p... | Class II | St. Jude Medical, Inc. |
| Sep 12, 2017 | Proclaim DRG Implantable Pulse Generator Model 3664 | Analysis of the difference between the actual device longevity and the battery indicator status p... | Class II | St. Jude Medical, Inc. |
| Sep 12, 2017 | Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Gener... | Analysis of the difference between the actual device longevity and the battery indicator status p... | Class II | St. Jude Medical, Inc. |
| Aug 14, 2017 | Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostat... | The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Pro... | Class II | Edap Technomed Inc. |
| Aug 8, 2017 | Alcon Custom Pak | Alcon is initiating a medical device recall, after receiving notification from a supplier of a re... | Class II | Alcon Research, LTD. |
| Aug 4, 2017 | MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numb... | It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to ... | Class II | Encore Medical, Lp |
| Aug 2, 2017 | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter wit... | Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has ha... | Class I | OriGen Biomedical, Inc. |
| Aug 2, 2017 | Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, n... | The plastic core of the Decorticating Planer was found to be missing, which could result in scori... | Class II | Orthofix, Inc |
| Jul 24, 2017 | COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit C... | Potential for partially incomplete seal of product, impacting sterility. | Class II | Epimed International |
| Jul 24, 2017 | TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic H... | Potential for partially incomplete seal of product, impacting sterility. | Class II | Epimed International |
| Jul 24, 2017 | RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plas... | Potential for partially incomplete seal of product, impacting sterility. | Class II | Epimed International |
| Jul 21, 2017 | SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. Th... | The plates do not have wells punched for the controls in the patient 1 area. | Class II | Helena Laboratories, Corp. |
| Jun 30, 2017 | ORA System with VerifEye, Catalog Number 8065998300 For use during intraocul... | Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract su... | Class II | Alcon Research, Ltd. |
| Jun 30, 2017 | ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during int... | Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract su... | Class II | Alcon Research, Ltd. |
| Jun 26, 2017 | Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Class II | Encore Medical, Lp |
| Jun 26, 2017 | Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERIL... | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Class II | Encore Medical, Lp |
| Jun 26, 2017 | Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Class II | Encore Medical, Lp |
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.