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 |
|---|---|---|---|---|
| Aug 16, 2023 | Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Fr... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Steri... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexne... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile. | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MH... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) ... | XXX | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced S... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Jun 16, 2023 | NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V1146... | Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regard... | Class II | Cardinal Health 200, LLC |
| Apr 6, 2023 | Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for... | Inadvertently released for distibution without sterility assurance. | Class II | Cardinal Health 200, LLC |
| Dec 14, 2022 | Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188 | 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-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 |
| 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 |
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.