Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 19, 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8... | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... | Class I | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Dec 16, 2022 | Low Flow Disposable Patient Circuit for the Precision Flow System, Product Co... | There have been reports of excessive condensation associated with certain lots of the Low Flow Di... | Class II | Vapotherm |
| Dec 16, 2022 | Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System | Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the syste... | Class II | NovaSignal Corp. |
| Dec 16, 2022 | HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 | Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... | Class II | Access Vascular, Inc |
| Dec 16, 2022 | System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Ar... | In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach f... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 16, 2022 | HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 | Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... | Class II | Access Vascular, Inc |
| Dec 16, 2022 | NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of Nova... | Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the syste... | Class II | NovaSignal Corp. |
| Dec 16, 2022 | Mammotome MammoStar Biopsy Site Identified, REF STAR1401 | The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loade... | Class II | Carbon Medical Technologies, Inc. |
| Dec 16, 2022 | HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 | Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... | Class II | Access Vascular, Inc |
| Dec 16, 2022 | ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor | Mechanical connection between the tabletop and table base may be lost. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 15, 2022 | HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Tech... | 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 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs P... | 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 PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy ... | 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 | PICC KIT, 10/CS, ACCESS MEDICAL LABEL | 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 | Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. | 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 Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags... | 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 NEONATAL PICC Tray *PGBK* 20 trays per case. Manufacture... | 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 | Henry Shein GLOVES, packaged in the following sizes and descriptions: a. G... | 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 | BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy o... | The affected product may contain a medium other than the Biopsy Medium. There is a risk that use... | Class II | CooperSurgical, Inc. |
| Dec 15, 2022 | Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to repla... | Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than th... | Class II | Biomet, Inc. |
| Dec 15, 2022 | AxiEM" Non-Invasive Patient Tracker | Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints an... | Class II | Medtronic Navigation, Inc. |
| Dec 15, 2022 | HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Pac... | 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 | 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 | Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative d... | Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that ... | Class II | Meridian Bioscience Inc |
| Dec 15, 2022 | HIGH V+ Spinal Cement System REF T040321K | Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration d... | Class II | TEKNIMED SAS |
| 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 |
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.