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 |
|---|---|---|---|---|
| Aug 22, 2023 | EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 | Knee insert and acetabular system parts were swapped within inner pack prior to the product being... | Class II | Encore Medical, LP |
| Aug 22, 2023 | EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H | Knee insert and acetabular system parts were swapped within inner pack prior to the product being... | Class II | Encore Medical, LP |
| Aug 22, 2023 | REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, ... | Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5... | Class II | Encore Medical, LP |
| Aug 8, 2023 | Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210 | Centered glenosphere box may contain an eccentric glenosphere. | Class II | FX SHOULDER |
| Aug 4, 2023 | DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, RE... | Orthopedic device components were not subjected to final sterilization before shipment, which if ... | Class II | Encore Medical, LP |
| Aug 4, 2023 | DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm,... | Orthopedic device components were not subjected to final sterilization before shipment, which if ... | Class II | Encore Medical, LP |
| Aug 4, 2023 | DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, R... | Orthopedic device components were not subjected to final sterilization before shipment, which if ... | Class II | Encore Medical, LP |
| Aug 4, 2023 | DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443 | Orthopedic device components were not subjected to final sterilization before shipment, which if ... | Class II | Encore Medical, LP |
| Aug 4, 2023 | DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 | Orthopedic device components were not subjected to final sterilization before shipment, which if ... | Class II | Encore Medical, LP |
| Jul 18, 2023 | Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: Th... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Pro... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Pro... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 14, 2023 | Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrog... | For administration of intravenous fluids to a patient s vascular system utilizing needle-free com... | Class II | Quest Medical, Inc. |
| Jun 8, 2023 | Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Fil... | There is the potential that the vena Cava Filter may not perform as intended which may result in ... | Class II | Argon Medical Devices, Inc |
| May 31, 2023 | REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, St... | Screws for osteotomies have contain an undersize screwhead which has the potential to pass throug... | Class II | Osteomed, LLC |
| May 31, 2023 | REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile | Screws for osteotomies have contain an undersize screwhead which has the potential to pass throug... | Class II | Osteomed, LLC |
| May 30, 2023 | Alinity ci-series System Control Module, REF: 03R70-01 | There are potential performance issues found in the Alinity ci-series System software versions 3.... | Class II | Abbott Laboratories |
| May 8, 2023 | Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12,... | Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer c... | Class II | Galt Medical Corporation |
| May 8, 2023 | Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 | Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer c... | Class II | Galt Medical Corporation |
| May 2, 2023 | Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spif... | Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator... | Class II | Helena Laboratories, Corp. |
| Apr 4, 2023 | GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1s... | Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm ... | Class II | GRAMERCY EXTREMITY ORTHOPEDICS |
| Mar 10, 2023 | Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 175... | Sterility; Steril surgical procedure packs contain incomplete seals. | Class II | Alcon Research, LLC |
| Feb 28, 2023 | EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella D... | Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porou... | Class II | Encore Medical, LP |
| Dec 23, 2022 | Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set wi... | Delivery Sets may have tubing that could become detached that could result in patient infection. | Class II | Quest Medical, Inc. |
| Dec 22, 2022 | EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE... | Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If t... | Class II | Encore Medical, LP |
| Nov 24, 2022 | Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHI... | Reaction vessels may contain a potential contaminant that could affect their optical performance. | Class III | Abbott Laboratories |
| Oct 31, 2022 | Alcon Custom Pak Surgical Procedure Pack | Due to difficulty removing the liner on the adhesive components of the affected drapes and as a r... | Class II | Alcon Research, LLC |
| Sep 14, 2022 | ARIES SARS-CoV-2 Assay, REF: 50-10047 | A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction ... | Class II | Luminex Corporation |
| Sep 1, 2022 | Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge... | Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the f... | Class II | Texas Medical Technology Inc. |
| Aug 12, 2022 | EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. | Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner impl... | Class II | Encore Medical, LP |
| Aug 12, 2022 | EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Or... | Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner impl... | Class II | Encore Medical, LP |
| Aug 10, 2022 | Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F),... | Bleed monitoring system device design error, causing the device to not power on and complete the ... | Class II | Saranas, Inc. |
| Jul 21, 2022 | Medline CHEST TUBE REORDER NO: DYNJ36762A | Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Co... | Class II | Medline Industries Inc. |
| Jul 14, 2022 | ARIES SARS-CoV-2 Assay | SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A pos... | Class II | Luminex Corporation |
| Jun 9, 2022 | Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 P... | Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves. | Class II | Alcon Research, LLC |
| Jun 9, 2022 | REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2... | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera... | Class II | Abbott Laboratories |
| Jun 9, 2022 | REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2... | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera... | Class II | Abbott Laboratories |
| Jun 9, 2022 | REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2... | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera... | Class II | Abbott Laboratories |
| May 5, 2022 | DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 | A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial ... | Class II | Encore Medical, LP |
| Apr 6, 2022 | V8 Immunodisplacement Kit REF 1803 | Due to microbial growth causing interference with interpretation. | Class II | Helena Laboratories, Corp. |
| Apr 5, 2022 | Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Veri... | Heater within the Verigene System may be outside of established temperature limits for assays wh... | Class II | Luminex Corporation |
| Apr 4, 2022 | Diagnostic Kit SARS-cCo V Antigen Rapid Test | COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the t... | Class II | USA Medical, LLC |
| Mar 16, 2022 | Separation Technology Creamatocrit Plus, Catalog Number: 100-146 | The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics ... | Class II | Stanbio Laboratory, LP |
| Feb 24, 2022 | Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Steri... | Surgical knives may contain incorrect description printed on handles. Specifically, some surgical... | Class II | International Science & Technology, LP, DBA Dia... |
| Feb 7, 2022 | Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS... | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to compl... | Class II | Brius Technologies Inc. |
| Feb 7, 2022 | Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX On... | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to compl... | Class II | Brius Technologies 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.