Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 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 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, RE... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, ... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10F... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CD... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS9... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DY... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYN... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995 | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF ... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TR... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| 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 | 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 | 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 |
| 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 1, 2023 | Infusomat Administration Sets as listed below: 362031 Infusomat Space Pu... | In affected products, the tubing outer diameter may vary in size or the length of tubing may be t... | Class I | B. Braun Medical, Inc. |
| Oct 16, 2023 | (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Train... | The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2023 | Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with ... | The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2023 | (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile... | The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 13, 2023 | Novum IQ Syringe infusion system, Product Code 40800BAXUS | Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter ident... | Class I | Baxter Healthcare Corporation |
| Oct 12, 2023 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC | There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... | Class I | Olympus Corporation of the Americas |
| Oct 12, 2023 | EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190 | There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... | Class I | Olympus Corporation of the Americas |
| Oct 12, 2023 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1T... | There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... | Class I | Olympus Corporation of the Americas |
| Oct 12, 2023 | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 B... | There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... | Class I | Olympus Corporation of the Americas |
| Oct 12, 2023 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 | There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... | Class I | Olympus Corporation of the Americas |
| Oct 12, 2023 | EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 an... | There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... | Class I | Olympus Corporation of the Americas |
| Oct 11, 2023 | VariSoft infusion set, Model Number 1002828 | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w... | Class I | Unomedical A/S |
| Oct 11, 2023 | VariSoft infusion set, Model Number 1002830 | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w... | Class I | Unomedical A/S |
| Oct 11, 2023 | VariSoft infusion set, Model Number 1002827 | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w... | Class I | Unomedical A/S |
| Oct 10, 2023 | CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOH... | Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This is... | Class I | Maquet Medical Systems USA |
| Oct 5, 2023 | CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with... | Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to incl... | Class I | Integra LifeSciences Corp. |
| Sep 28, 2023 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 | Defective video laryngoscopes that did not pass quality tests established for the product, that w... | Class I | Covidien |
| Sep 27, 2023 | StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The Ste... | Due to a software anomaly which potentially could result in the surgical planning data shifting t... | Class I | Medtronic Navigation, Inc. |
| Sep 26, 2023 | Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208,... | Non-sterile product labeled as sterile was distributed. | Class I | Cordis US Corp |
| Sep 22, 2023 | Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. | There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, dur... | Class I | Olympus Corporation of the Americas |
| Sep 21, 2023 | 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System | Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In... | Class I | B. Braun Medical, Inc. |
| Sep 21, 2023 | 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric ... | Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In... | Class I | B. Braun Medical, Inc. |
| Sep 20, 2023 | Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 20, 2023 | Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 20, 2023 | Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 20, 2023 | Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 20, 2023 | Monoject 20 mL Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 20, 2023 | Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 15, 2023 | Alaris PCA Module 8120 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... | Class I | CareFusion 303, Inc. |
| Sep 15, 2023 | BD Alaris PCU REF 8015 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... | Class I | CareFusion 303, Inc. |
| Sep 15, 2023 | BD Alaris Syringe Module, REF 8110 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... | Class I | CareFusion 303, Inc. |
| Sep 15, 2023 | Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ... | Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Sur... | Class I | Asensus Surgical 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.