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 |
|---|---|---|---|---|
| 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. |
| Mar 2, 2017 | Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA so... | Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VM... | Class II | Ortho Kinematics, Inc |
| Feb 28, 2017 | The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the... | The potential hazard that can arise for the combination of the missing screws and the overloading... | Class II | Stryker Communications |
| Feb 24, 2017 | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at ... | Due to some cards in this lot reported to have experienced variations in results, (verified by wa... | Class II | Helena Laboratories, Inc. |
| Feb 9, 2017 | RSP Impaction Fixture | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from t... | Class II | Encore Medical, Lp |
| Feb 9, 2017 | Turon Impaction Fixture | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from t... | Class II | Encore Medical, Lp |
| Jan 18, 2017 | BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for... | The recalling firm received a complaint from one of their customers of a potential defect in the ... | Class II | Argon Medical Devices, Inc |
| Jan 18, 2017 | T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEED... | The recalling firm received a complaint from one of their customers of a potential defect in the ... | Class II | Argon Medical Devices, Inc |
| Jan 18, 2017 | HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or... | The recalling firm received a complaint from one of their customers of a potential defect in the ... | Class II | Argon Medical Devices, Inc |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 11, 2017 | Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quanti... | Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read ... | Class II | Ortho Kinematics, Inc |
| Jan 10, 2017 | Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert a... | The Empowr PS Insert was reported as missing the impaction slot feature. | Class II | Encore Medical, Lp |
| Jan 10, 2017 | LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Mo... | Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal ... | Class II | Encore Medical, Lp |
| Dec 13, 2016 | Chord-X Chordal Sizer is designed to assist in determining the proper length ... | Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Lef... | Class II | On-X Life Technologies, Inc. |
| Dec 8, 2016 | Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O ... | Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a pri... | Class II | Trilliant Surgical Ltd. |
| Nov 15, 2016 | Empowr Knee System Product Usage: Non-porous proximal tibial baseplate im... | A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, ma... | Class II | Encore Medical, Lp |
| Nov 7, 2016 | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase I... | Due to a customer experiencing complaints on bone fraction of assay not being in range. The co... | Class III | Helena Laboratories, Inc. |
| Oct 14, 2016 | Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL | Due to customer-experienced complaints on narrow assay range compared to prior lots and the user ... | Class II | Helena Laboratories, Inc. |
| Oct 4, 2016 | Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ... | Potential contamination with B. cepacia. | Class I | Nurse Assist, Inc |
| Sep 19, 2016 | Empowr PS Knee System Box Cut Guide; Used to make the housing resection for ... | It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone rem... | Class II | Encore Medical, Lp |
| Sep 19, 2016 | Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to ... | It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone rem... | Class II | Encore Medical, Lp |
| Sep 8, 2016 | MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. ... | The supplier initiated a recall because affected lots of the micro-introducer have an outer diame... | Class II | Argon Medical Devices, Inc |
| Sep 7, 2016 | Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily im... | The device has the potential to be packaged in the wrong product box. | Class II | Osteogenics Biomedical, Inc. |
| Sep 5, 2016 | Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySo... | The intraocular lens could become lodged within the cartridge | Class II | Alcon Research, Ltd. |
| Sep 2, 2016 | Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 ... | Screws were identified as having the incorrect part number and lot number marked upon them. The ... | Class II | Trilliant Surgical Ltd. |
| Aug 29, 2016 | ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model... | The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of ... | Class II | LDR Spine USA, Inc. |
| Aug 12, 2016 | Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. ... | Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug... | Class II | Ortho Kinematics, Inc |
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.