Browse Device Recalls
302 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 302 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 302 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| Feb 25, 2021 | Femoral Angiography Drape Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 25, 2021 | Femoral Angiography Drape Bulk Non-Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 25, 2021 | In-View Clear Leggings Sterile Non-Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 25, 2021 | In-View Clear Leggings Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 11, 2021 | JUDKINS PACK | Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) ... | Class II | Cardinal Health 200, LLC |
| Feb 9, 2021 | Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single ... | Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... | Class II | Cardinal Health 200, LLC |
| Feb 9, 2021 | Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x ... | Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... | Class II | Cardinal Health 200, LLC |
| Feb 9, 2021 | McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen ... | Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... | Class II | Cardinal Health 200, LLC |
| Jan 19, 2021 | Enteral Infusion Pump | The potential for air appearing in the enteral feed pumping set tubing during set-up. | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, La... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004 | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, La... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG,... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab ... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat,... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium a... | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab C... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, L... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | ChemoPlus" Chemo Prep & Admin Kit, CT4025 | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... | 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.