Browse Device Recalls

275 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 275 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 275 FDA device recalls.

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DateProductReasonClassFirm
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Nov 18, 2022 Cardinal Health Presource Packs IV START KIT- 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 18, 2022 Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG ... Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... Class II Cardinal Health 200, LLC
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
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
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

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.