November 20, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Lab Kit, SKU DYLAB1018; Component No. 503581
Hazard: 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.
November 20, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Clean Catch Kit, SKU DYKM1833A; Component No. 503581
Hazard: 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.
November 20, 2024Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Zenition 70, Model Number: 718133
Hazard: Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
November 20, 2024Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Zenition 50, Model Number: 718096
Hazard: Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
November 20, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Produ
Hazard: 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.
November 20, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
Hazard: 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.
November 20, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Hazard: 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.
November 20, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Hazard: The door on the Spectrum IQ Infusion pump may not be able to fully close.
November 20, 2024Medical DevicesFDA
Cook Incorporated recalls Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-
Hazard: Affected device lots have labels that state the incorrect expiration dates.
November 20, 2024Medical DevicesFDA
Cook Incorporated recalls Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18
Hazard: Affected device lots have labels that state the incorrect expiration dates.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contai
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic inten
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic inten
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to conta
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to conta
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to conta
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to conta
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
The Metrix Company recalls VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to conta
Hazard: A limited number of IV bags have been found to leak during filling.
November 20, 2024Medical DevicesFDA
WISSNER-BOSSERHOFF GMBH recalls SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-01
Hazard: 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.
November 20, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is
Hazard: 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.
November 20, 2024Medical DevicesFDA
FHC, Inc. recalls microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode o
Hazard: 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.
November 20, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Hazard: 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.