Browse Device Recalls
432 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 432 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 432 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 28, 2022 | Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Mar 15, 2022 | Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves | Product was distributed without being sterilized. | Class II | Cardinal Health 200, LLC |
| Nov 2, 2021 | RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-li... | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long ... | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Aug 19, 2021 | Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 888157012... | Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits.... | Class I | Windstone Medical Packaging, Inc. |
| Aug 4, 2021 | Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Cod... | Potential for the plunger to draw back after the air has been expelled and reintroduce air back i... | Class I | Cardinal Health |
| Aug 4, 2021 | Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code... | Potential for the plunger to draw back after the air has been expelled and reintroduce air back i... | Class I | Cardinal Health |
| Aug 4, 2021 | Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code ... | Potential for the plunger to draw back after the air has been expelled and reintroduce air back i... | Class I | Cardinal Health |
| Jul 12, 2021 | Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vi... | Deterioration in the stability of the reagents which has resulted in lower than expected or out o... | Class III | Stanbio Laboratory, LP |
| Jul 12, 2021 | Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower than expected or out o... | Class III | Stanbio Laboratory, LP |
| Jun 16, 2021 | Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 7... | The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalp... | Class I | Cardinal Health 200, LLC |
| Jun 9, 2021 | Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU M... | A caution statement is being added to remind the user to activate away from face and infant as r... | Class II | Cardinal Health 200, LLC |
| Jun 9, 2021 | Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH000... | A caution statement is being added to remind the user to activate away from face and infant as r... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usag... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Pro... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product ... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - P... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Numbe... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Ca... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| Mar 16, 2021 | ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | FREESTYLE LANCETS 28G 100CT Item Number:2975670 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | BD UF PEN 32GX4MM 100 NANO Item Number: 4292272 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | VAPORIZER VICKS 1.5GAL Item Number: 2354942 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | DEXCOM G6 SENSOR 3 PACK Item Number: 5447552 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Feb 25, 2021 | In-View Clear Leggings Bulk Non-Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, 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.