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 |
|---|---|---|---|---|
| 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 |
| Jun 26, 2017 | Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERIL... | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Class II | Encore Medical, Lp |
| Jun 13, 2017 | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No... | Manufacturing process used to assemble the circuit board may result in some devices experiencing ... | Class II | Cyberonics, Inc |
| Jun 13, 2017 | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No... | Manufacturing process used to assemble the circuit board may result in some devices experiencing ... | Class II | Cyberonics, Inc |
| Jun 2, 2017 | Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO ... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Pro... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO ... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Pro... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, P... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Pro... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| May 31, 2017 | 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 0... | Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibia... | Class II | Encore Medical, Lp |
| May 31, 2017 | 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01... | Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibia... | Class II | Encore Medical, Lp |
| May 25, 2017 | LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmi... | Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the micros... | Class II | Alcon Research, Ltd. |
| May 11, 2017 | Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G A... | Argon Medical has received a complaint from one of their distributors of a potential packaging de... | Class II | Argon Medical Devices, Inc |
| Apr 28, 2017 | 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Pa... | Potential sterile barrier breach | Class II | KCI USA, INC. |
| Apr 21, 2017 | Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are med... | The exam light may have a tolerance issue with the adapter assembly, which could potentially not ... | Class II | Stryker Communications |
| Apr 19, 2017 | ARIES System and ARIES M1 System | The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen i... | Class II | Luminex Corporation |
| Apr 4, 2017 | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitatio... | Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Pro... | Class II | Helena Laboratories, Inc. |
| Mar 27, 2017 | Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblag... | Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated th... | Class II | Alcon Research, Ltd. |
| Mar 27, 2017 | Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Impl... | Missing Dome Pack accessory. | Class II | Mentor Texas, 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.