Browse Device Recalls
2,601 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,601 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 2,601 FDA device recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 20, 2023 | KeySplint Hard Clear - Indicated for the fabrication of orthodontic and denta... | Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instr... | Class II | Keystone Industries |
| Nov 20, 2023 | AirFit F30 Full Face Mask and User Guide | Masks non-invasive interface for channeling airflow to patients have magnets that have potential ... | Class I | ResMed Ltd. |
| Nov 20, 2023 | AirTouch N20 Nasal Mask and User Guide | Masks non-invasive interface for channeling airflow to patients have magnets that have potential ... | Class I | ResMed Ltd. |
| Nov 20, 2023 | Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) | There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoC... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Nov 20, 2023 | AirTouch F20 Full Face Mask and User Guide | Masks non-invasive interface for channeling airflow to patients have magnets that have potential ... | Class I | ResMed Ltd. |
| Nov 20, 2023 | Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry... | Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-ass... | Class II | Randox Laboratories Ltd. |
| Nov 20, 2023 | Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-... | Seal defects could compromise the ability of the product packaging to maintain sterility. | Class II | Medtronic Inc. |
| Nov 20, 2023 | Regard Dressing change kit, Item Number 800026006 | ROi CPS manufactured and distributed medical convenience kits with an irrigation solution compone... | Class I | ROi CPS LLC |
| Nov 20, 2023 | OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S1... | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in t... | Class II | Olympus Corporation of the Americas |
| Nov 17, 2023 | Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atla... | Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains... | Class II | Draegerwerk Ag & Co. Kgaa |
| Nov 17, 2023 | VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number... | Cassette did not meet an 1n-process flow criterion. | Class II | Vero Biotech, LLC |
| Nov 17, 2023 | Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 7... | Firm was informed of an event in which the structural integrity of the MR system components faile... | Class I | Philips North America Llc |
| Nov 16, 2023 | PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syri... | An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with... | Class II | Becton Dickinson & Company |
| Nov 16, 2023 | Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10G... | Due to software issue, New systems may exhibit an error which may prohibit use of new systems res... | Class II | Covidien |
| Nov 16, 2023 | AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -int... | Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentia... | Class II | Covidien LP |
| Nov 16, 2023 | V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoc... | Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. Th... | Class II | Steris Corporation |
| 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 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 | 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 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 | 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 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CD... | 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) DIALYSIS ACCESSOR... | 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) ANTERIOR PACK, REF D... | 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: MAINTENANCE FLUSH KIT/B... | 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) PORT ACCESS TRAY, 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) D&C CDS, REF CDS9839... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System | New User Manual with additional instructions for use and a hose and mask adapter provided by the ... | Class II | SoClean, Inc |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTO... | 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: DIALYSIS ON/OFF BNDLE -... | 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) A C DAILY WET KIT,... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3... | Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.... | Class II | Medtronic MiniMed, Inc. |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX... | 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) DIALYSIS ACCESSORY... | 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: BREAST BIOPSY KIT, RE... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Sp... | Incorrect product labeling. Exterior product box label does not match internal pouch label. | Class II | Spectranetics Corporation |
| Nov 15, 2023 | Sensica Urine Output System, Catalog Number SCCS1002 | BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/... | Class II | C.R. Bard Inc |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010 | 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) NUR 105, REF EDUC050... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | The device is an X-ray system that is capable of radiographic and fluoroscopi... | VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal image... | Class II | Canon Medical System, USA, INC. |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KI... | 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: SERUM TEAR KIT, REF DYNDA... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, la... | 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: CIRCUMCISION TRAY, 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) 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) LACERATION KIT, 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) C-SECTION, REF DYNJ9... | 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) 709E RECOVERY PACK A... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
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.