Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-06-27FDA-DeviceZimmer Biomet, Inc.Class IIG-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
- 2018-06-27FDA-DeviceZimmer Biomet, Inc.Class IIG-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
- 2018-06-27FDA-DeviceZimmer Biomet, Inc.Class IIG-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
- 2018-06-27FDA-DeviceZimmer Biomet, Inc.Class IIBALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
- 2018-06-27FDA-DeviceZimmer Biomet, Inc.Class IIGUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
- 2018-06-27FDA-DeviceZimmer Biomet, Inc.Class IIBALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
- 2018-06-27FDA-DeviceZimmer Biomet, Inc.Class IIBALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
- 2018-06-27FDA-DeviceZimmer Biomet, Inc.Class IIDRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
- 2018-06-27FDA-DeviceZimmer Biomet, Inc.Class IIDRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
- 2018-06-20FDA-DeviceSafe N Simple, LLCClass IIDermaPro Waterproof Silicone Tape, SNS57232
The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion.
- 2018-06-20FDA-DeviceThe Seaberg Company IncClass IIPart #: SAM XT-C, Model: Hi-Viz Blue
Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.
- 2018-06-20FDA-DeviceThe Seaberg Company IncClass IIPart #: SAM XT-C, Model: Hi-Viz Orange or Civilian
Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.
- 2018-06-20FDA-DeviceThe Seaberg Company IncClass IIPart #: SAM XT-M, Model: Tactical Black or Military
Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS 5F DL XCELA PICC, Catalog Number 60M122272
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIXcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IICAN 5F DUAL XCELA PICC, Catalog Number 60M701532
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IICAN 5F SINGLE XCELA PICC, Catalog Number 60M701531
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IICAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS 5F DL BIOFLO PASV, Catalog Number 60M183481
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS 5F DL XPP KIT, Catalog Number 60M183104
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS 5F DL BIOFLO PASV, Catalog Number 60M181578
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class II5F DL BIOFLO PICC, Catalog Number 60M180592
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS 5F DL BIOFLO PASV, Catalog Number 60M161567
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
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