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 4, 2020 | VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 81... | False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output curren... | Class II | LivaNova USA Inc |
| Dec 17, 2019 | Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168... | Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or ... | Class II | Quest Medical, Inc. |
| Dec 4, 2019 | 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 1141... | The stiffness of the soft end of the guidewire caused tissue perforation. | Class I | Argon Medical Devices, Inc |
| Dec 4, 2019 | 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114... | The stiffness of the soft end of the guidewire caused tissue perforation. | Class I | Argon Medical Devices, Inc |
| Dec 2, 2019 | BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial... | Incorrect product labeling. | Class II | Argon Medical Devices, Inc |
| Nov 4, 2019 | 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: ... | The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain th... | Class II | Trilliant Surgical, LLC |
| Oct 22, 2019 | EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026... | The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking d... | Class II | Encore Medical, LP |
| Oct 11, 2019 | Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 | The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may ... | Class II | Stryker Communications |
| Oct 10, 2019 | 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Steri... | Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL0... | Class II | Trilliant Surgical, LLC |
| Aug 22, 2019 | VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal ne... | Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-en... | Class I | LivaNova USA Inc |
| Aug 21, 2019 | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307. | Reports received of the device fracturing during insertion. | Class II | CTL Medical Corporation |
| Aug 21, 2019 | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308. | Reports received of the device fracturing during insertion. | Class II | CTL Medical Corporation |
| Aug 21, 2019 | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908. | Reports received of the device fracturing during insertion. | Class II | CTL Medical Corporation |
| Aug 21, 2019 | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907. | Reports received of the device fracturing during insertion. | Class II | CTL Medical Corporation |
| Aug 14, 2019 | Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A | Due to manufacturing processing error, wrench causing stripping when torqueing nuts. | Class II | New Standard Device Inc |
| Aug 13, 2019 | VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1... | Firm identified a subset of its generators that were sterilized one additional sterilization cycl... | Class II | LivaNova USA Inc |
| Aug 6, 2019 | BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors... | The device data being collected and transferred to the monitoring center may not be accurate due ... | Class II | Preventice Services, LLC |
| Aug 1, 2019 | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a componen... | The mounts on the monitor may have an insufficient weld. | Class II | Stryker Communications |
| Jul 23, 2019 | 'n'-Hole Post which is a component of the Revolution External Fixation System... | The threads on posts stripping out when tensioned during application process. | Class II | New Standard Device Inc |
| Jul 23, 2019 | AggreGuide A-100 Instrument | The firm identified a software design issue where the improper shut down of the instrument result... | Class II | Aggredyne, Inc. |
| Jul 16, 2019 | Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; R... | There was incorrect raw material used in the production of the identified lot. | Class II | TeDan Surgical Innovations LLC |
| Jun 24, 2019 | 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile E... | The firm has become aware that they have distributed product that was expired. | Class II | OriGen Biomedical, Inc. |
| Jun 6, 2019 | OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturi... | A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the... | Class II | Skeletal Kinetics, Llc |
| Jun 6, 2019 | OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturin... | A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the... | Class II | Skeletal Kinetics, Llc |
| Jun 4, 2019 | inLight Medical LED Pads used with Polychromatic light technology system | LED pads with cord connectors that have v-shaped notches may not have been assembled properly. Th... | Class III | Inlightened Partners LLC |
| May 22, 2019 | "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR... | Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The ma... | Class II | Abbott Laboratories |
| May 1, 2019 | ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry Sy... | Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result ... | Class II | Abbott Laboratories, Inc |
| Apr 15, 2019 | PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. | There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Posi... | Class II | Hitachi America, Ltd., Power Systems Division |
| Mar 22, 2019 | Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical ... | The back cover of the light head was insufficiently assembled and could potentially fall off the ... | Class II | Stryker Communications |
| Mar 22, 2019 | Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical ... | The back cover of the light head was insufficiently assembled and could potentially fall off the ... | Class II | Stryker Communications |
| Mar 18, 2019 | IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the follow... | The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve... | Class II | Ideal Implant Incorporated |
| Mar 14, 2019 | Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver... | A screwdriver used to facilitate implant insertion and removal was found to be out of specificati... | Class II | Trilliant Surgical, LLC |
| Feb 21, 2019 | Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE ... | The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper... | Class II | ArthroCare Corporation |
| Feb 20, 2019 | ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | ARIES GBS Assay , REF 50-10021, UDI # 00840487100165 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 20, 2019 | ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295 | Through internal investigation, it was discovered that a portion of side cassette assemblies (S... | Class II | Luminex Corporation |
| Feb 18, 2019 | DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: The... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: The... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 4, 2019 | EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument ... | The firm has received reports/complaints concerning the breakage of the tips of the locking femo... | Class II | Encore Medical, Lp |
| Jan 18, 2019 | SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product U... | Cosmetic Kit was packaged with a mislabel medical product. | Class II | Bellus Medical |
| Jan 7, 2019 | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z ... | Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly ... | Class II | Acuity Surgical Devices, LLC |
| Jan 7, 2019 | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z ... | Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly ... | Class II | Acuity Surgical Devices, LLC |
| Jan 2, 2019 | ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is u... | Abbott internal testing has identified that the Magnesium urine application demonstrates depresse... | Class II | Abbott Laboratories, Inc |
| Dec 26, 2018 | Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) G... | On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplifica... | Class III | Luminex Corporation |
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.