Browse Device Recalls

441 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 441 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 441 FDA device recalls.

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DateProductReasonClassFirm
Nov 18, 2022 Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device... Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... Class II Cardinal Health 200, LLC
Nov 1, 2022 Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch ... Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... Class II Cardinal Health
Nov 1, 2022 Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Cathet... Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... Class II Cardinal Health
Nov 1, 2022 Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended... Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... Class II Cardinal Health
Nov 1, 2022 Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Cathet... Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... Class II Cardinal Health
Nov 1, 2022 Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch ... Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... Class II Cardinal Health
Nov 1, 2022 Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter... Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... Class II Cardinal Health
Sep 28, 2022 Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104 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 HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304 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, 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.

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.