Browse Device Recalls
3,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,428 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 3,428 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 8, 2023 | Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode... | Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec... | Class I | Megadyne Medical Products, Inc. |
| Dec 8, 2023 | Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Elec... | Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec... | Class I | Megadyne Medical Products, Inc. |
| Dec 8, 2023 | Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reu... | Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec... | Class I | Megadyne Medical Products, Inc. |
| Dec 8, 2023 | Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode... | Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec... | Class I | Megadyne Medical Products, Inc. |
| Dec 7, 2023 | ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 | A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGP... | Class I | Globus Medical, Inc. |
| Dec 4, 2023 | Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC,... | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
| Dec 4, 2023 | Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, ... | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
| Dec 4, 2023 | Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PRO... | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
| Dec 4, 2023 | Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRA... | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
| Dec 4, 2023 | TRACH KIT W/HYDROGEN & SALI | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
| Dec 4, 2023 | Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC... | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
| Dec 4, 2023 | Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DR... | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
| Dec 4, 2023 | Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0... | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
| Dec 4, 2023 | Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE,... | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
| Dec 4, 2023 | Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC... | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
| Nov 30, 2023 | Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.... | The bolus calculator is not recording the decimal point if it is the first value entered when cha... | Class I | Insulet Corporation |
| Nov 30, 2023 | Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE | Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... | Class I | Busse Hospital Disposables, Inc. |
| Nov 30, 2023 | Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE | Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... | Class I | Busse Hospital Disposables, Inc. |
| Nov 30, 2023 | Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE | Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... | Class I | Busse Hospital Disposables, Inc. |
| Nov 29, 2023 | Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 | The device may experience mechanical interference on the Fluid Valve pins, which will trigger a P... | Class I | Fresenius Kabi USA, LLC |
| 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 | 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 | AirFit N10 Nasal Masks 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 | AirFit F30i 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 | 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 | AirFit 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 | AirFit 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 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 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 | 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) PORT REMOVAL PACK, R... | 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 | Medline Kits, trays, and packs labeled as follows: a) TRACH CARE 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 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 | 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) 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) 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) 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 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 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 |
| 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 | 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 | 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) C L PREP, REF DYNJ69... | 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) CENTRAL LINE TRAY, R... | 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 | 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 | MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1... | 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 |
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.