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 |
|---|---|---|---|---|
| Apr 22, 2024 | 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Apr 22, 2024 | ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Mar 18, 2024 | LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019,... | Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to ... | Class II | XENEX Disinfection Services Inc. |
| Mar 15, 2024 | Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang... | Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. | Class II | Alcon Research, LLC |
| Feb 21, 2024 | SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pa... | Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be br... | Class II | Alcon Research, LLC |
| Feb 8, 2024 | Chromophare Surgical Light System , REF CH00000001 | Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. | Class II | Stryker Communications |
| Feb 5, 2024 | EasyPoint Needle, 25G x 5/8", REF: 82091 | The needle cannula of a retractable needle may detach from the needle holder in the patient. | Class II | Retractable Technologies, Inc. |
| Dec 19, 2023 | Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD ... | Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to ... | Class II | OriGen Biomedical, Inc. |
| Nov 10, 2023 | DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 L... | Due to incorrect product/device within packaging. | Class II | Encore Medical, LP |
| Nov 6, 2023 | 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/... | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside... | Class I | Nurse Assist, LLC |
| Nov 6, 2023 | Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100M... | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside... | Class I | Nurse Assist, LLC |
| Nov 6, 2023 | Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID ... | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside... | Class I | Nurse Assist, LLC |
| Nov 6, 2023 | Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SY... | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside... | Class I | Nurse Assist, LLC |
| Nov 6, 2023 | 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10M... | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside... | Class I | Nurse Assist, LLC |
| Oct 24, 2023 | CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A | There is the potential that cooler-heater devices may contain bacterial contamination which could... | Class II | CardioQuip, LLC |
| Oct 24, 2023 | CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A | There is the potential that cooler-heater devices may contain bacterial contamination which could... | Class II | CardioQuip, LLC |
| Oct 19, 2023 | ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... | Class II | Abbott Laboratories |
| Oct 19, 2023 | CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the h... | Class II | CardioQuip, LLC |
| Oct 19, 2023 | Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... | Class II | Abbott Laboratories |
| Oct 19, 2023 | Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... | Class II | Abbott Laboratories |
| Oct 19, 2023 | CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the h... | Class II | CardioQuip, LLC |
| Oct 5, 2023 | REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 | Mislabeling | Class II | Encore Medical, LP |
| Oct 5, 2023 | Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32... | Mislabeling | Class II | Encore Medical, LP |
| Oct 2, 2023 | STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vit... | Deterioration in the stability of the Test Strips results in diminished low-range detection capab... | Class II | Stanbio Laboratory, LP |
| Sep 29, 2023 | DJO EMPOWR Knee Punch Handle, REF: 801-05-040 | Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lea... | Class II | Encore Medical, LP |
| Sep 25, 2023 | RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: ... | Two different humeral socket Insert devices were swapped during packaging, which could result in ... | Class II | Encore Medical, LP |
| Sep 25, 2023 | RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, ... | Two different humeral socket Insert devices were swapped during packaging, which could result in ... | Class II | Encore Medical, LP |
| Sep 7, 2023 | Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARAC... | Custom surgical procedure packs contain latex gloves but are labeled as "latex free". | Class II | Alcon Research, LLC |
| Sep 6, 2023 | RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical sho... | Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver | Class II | Encore Medical, LP |
| Aug 30, 2023 | CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Genera... | Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance c... | Class II | RoyalVibe Health Ltd. |
| Aug 24, 2023 | Various Medical Products stored on pallets, including but not limited to band... | Various medical devices potentially exposed to rodent and rodent activity. In addition, medical d... | Class II | Inmar Supply Chain Solutions, LLC |
| 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 |
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.