Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-11-20FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IILab Kit, SKU DYLAB1018; Component No. 503581
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- 2024-11-20FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIClean Catch Kit, SKU DYKM1833A; Component No. 503581
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- 2024-11-20FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Zenition 70, Model Number: 718133
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
- 2024-11-20FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Zenition 50, Model Number: 718096
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
- 2024-11-20FDA-DeviceOlympus Corporation of the AmericasClass IIBrand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.
- 2024-11-20FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
- 2024-11-20FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
- 2024-11-20FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
The door on the Spectrum IQ Infusion pump may not be able to fully close.
- 2024-11-20FDA-DeviceCook IncorporatedClass IIApproach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Affected device lots have labels that state the incorrect expiration dates.
- 2024-11-20FDA-DeviceCook IncorporatedClass IIApproach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
Affected device lots have labels that state the incorrect expiration dates.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IIImed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IIImed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IIImed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IIImed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IISECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IISECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IISECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IISECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IISECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IISECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IISECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IICORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IICORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IICORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IIVYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceThe Metrix CompanyClass IIVYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
- 2024-11-20FDA-DeviceWISSNER-BOSSERHOFF GMBHClass IISafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
When the handset is disconnected from the power mains, and mains operation is restored, the handset is reset to the preset Resident mode. In this mode, the backrest, legrest, and height adjustment can be moved.
- 2024-11-20FDA-DeviceBaxter Healthcare CorporationClass IBaxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- 2024-11-20FDA-DeviceFHC, Inc.Class ImicroTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.
- 2024-11-20FDA-DeviceCardinal Health 200, LLCClass IMonoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
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