Browse Device Recalls
3,306 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,306 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 3,306 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 15, 2022 | PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosp... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vi... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and ca... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per ba... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care T... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Heal... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by ... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| 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 |
| Dec 9, 2022 | Alinity m System. The Alinity m System is designed to automate the steps... | The firm identified the following three potential issues which may have impacted ADUs installed o... | Class II | Abbott Molecular, Inc. |
| Dec 7, 2022 | Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRA... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reo... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Num... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Nu... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUM... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISI... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOM... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST T... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder N... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRA... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.