Browse Device Recalls
3,367 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,367 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 3,367 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 20, 2023 | These wipes are saturated with 0.65% bleach solution. These wipes are antimic... | There is stability concern for products dated with a 24-month shelf life. Product is safe and eff... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 8, 2023 | XScribe Cardiac Stress Testing System, version 6, with below product names an... | Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F... | Class II | Baxter Healthcare Corporation |
| Dec 8, 2023 | Q-Stress Cardiac Stress Testing System, version 6, with below product name / ... | Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F... | Class II | Baxter Healthcare Corporation |
| Dec 8, 2023 | XScribe CP Cardiac Stress Testing System, version 6, with below product names... | Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC12... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5m... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) P... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, ... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 15... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Preveleak Surgical Sealant, Product Codes: ADS201808 | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: ... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 9340... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG04... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the fo... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883 | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 m... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100,... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| 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 | 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 | 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" 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 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 | 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" 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 |
| 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 | 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" 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 |
| Nov 29, 2023 | Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2... | Surgical gowns were manufactured with the wrong sleeve. | Class II | 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 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 | 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 | 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 | 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 |
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.