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.

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DateProductReasonClassFirm
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.