Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 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 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 3, 2021 | Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7m... | Incorrect product is contained in the packaging. | Class II | Wright Medical Technology, Inc. |
| Dec 3, 2021 | Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm. | The incorrect product is contained in the packaging. | Class II | Wright Medical Technology Inc |
| Dec 2, 2021 | Zenition 70, Model #718133 | Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issu... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 2, 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Returned test kits were erroneously shipped to customers. The kits are intended for Research Use ... | Class I | CELLTRION USA INC |
| Dec 2, 2021 | Veradius Unity, Model #718132 | Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issu... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 2, 2021 | IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neur... | Tile kits that allow one to install and situate a video camera within a patient environment are n... | Class II | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Dec 2, 2021 | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Mode... | A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation lea... | Class II | LivaNova USA, Inc. |
| Dec 2, 2021 | Zenition 50, Model #718096 | Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issu... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 1, 2021 | Michels Transport Medium, 20ML Prefilled Cont | Product stored incorrectly in temperature controlled setting instead of refrigeration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 1, 2021 | Premier Rotaclone, Rx only | Product stored incorrectly in temperature controlled setting instead of refrigeration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 1, 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 dis... | The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the ... | Class II | CELLTRION USA INC |
| Dec 1, 2021 | HARDY DIAGNOSTICS CatScreen, 25dsk/vial | Product stored incorrectly in temperature controlled setting instead of refrigeration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 1, 2021 | Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 | There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated... | Class II | Maquet Cardiovascular, LLC |
| Dec 1, 2021 | Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in t... | ¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. P... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 30, 2021 | Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605 | Affected product was shipped from the warehouse at room temperature instead of the required refri... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 30, 2021 | activforce 2 package labeling: Model: Activ5-M R 201-200563 | Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may ... | Class II | Activbody, Inc. |
| Nov 30, 2021 | Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual... | Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may ... | Class II | Activbody, Inc. |
| Nov 30, 2021 | Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental impl... | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant w... | Class II | Straumann USA LLC |
| Nov 30, 2021 | Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant w... | Class II | Straumann USA LLC |
| Nov 30, 2021 | Regard, T AND A - Rogers, sterilized convenience kits | Kits lacks rubber latex warning label. | Class II | ROi CPS LLC |
| Nov 29, 2021 | Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 29, 2021 | Infant Heel Warmers w/strap, Reference # 989805603201 1223 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 29, 2021 | Proteus 235; Version: PTS-8 versions before PTS-8.7.2 | Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) ... | Class II | Ion Beam Applications S.A. |
| Nov 29, 2021 | Heel Snuggler, Reference # 989805603411 99047 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 29, 2021 | Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 26, 2021 | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 24, 2021 | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF ... | Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orie... | Class II | Reflexion Medical, Inc. |
| Nov 24, 2021 | Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a ... | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... | Class II | Philips North America Llc |
| Nov 24, 2021 | Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage... | Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel ... | Class II | Howmedica Osteonics Corp. |
| Nov 24, 2021 | Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluorosco... | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... | Class II | Philips North America Llc |
| Nov 24, 2021 | DBB-06 Hemodialysis Delivery System | Device lacks premarket approval. | Class II | Nikkiso Ltd - Shizuoka Plant |
| Nov 23, 2021 | 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, mat... | Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 22, 2021 | WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval ... | Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under s... | Class I | Cardiovascular Systems Inc |
| Nov 22, 2021 | BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement f... | Product was distributed with incorrect expiration date. | Class II | Avanos Medical, Inc. |
| Nov 22, 2021 | VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack | Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted w... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Nov 22, 2021 | UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, ... | The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed thro... | Class II | Uromedica Inc. |
| Nov 22, 2021 | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 | This recall has been initiated to provide a labeling update with revised instruction how to opera... | Class II | Gentherm Medical, LLC |
| Nov 22, 2021 | BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French;... | Product was distributed with incorrect expiration date. | Class II | Avanos Medical, Inc. |
| Nov 22, 2021 | BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French;... | Product was distributed with incorrect expiration date. | Class II | Avanos Medical, Inc. |
| Nov 21, 2021 | QIAcube Connect MDx, Model No. 9003070 | During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minima... | Class II | Qiagen Sciences LLC |
| Nov 19, 2021 | Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 | A subset of affected discs are at risk of leakage when it is used more than one time with Simplex... | Class II | DiaSorin Molecular LLC |
| Nov 19, 2021 | Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU T... | The Instructions for Use provided with the device contained information intended for use of a mec... | Class III | Ki Mobility Llc |
| Nov 19, 2021 | Instructions for Use for all model numbers of the Medtronic Abre Venous Self-... | There have been reports of stent migration. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 19, 2021 | SOMATOM Confidence -Computed tomography systems Model 10590100 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | Philips Allura Xper FD series with Software Version Number: 2.1.x- intended f... | Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mount... | Class II | Philips North America Llc |
| Nov 19, 2021 | Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set... | Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest w... | Class II | Medtronic Sofamor Danek USA Inc |
| Nov 19, 2021 | SOMATOM Definition Edge -Computed tomography system Model 10590000 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Definition AS-Computed tomography system Model 8098027 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Edge Plus-Computed tomography system Model 1026700 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 18, 2021 | Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automat... | (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for O... | Class II | Siemens Healthcare Diagnostics, Inc. |
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.