Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
Cardinal Health
Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Y-Type Blood Set, Catalog Number 490425
B. Braun Medical
Class I - Dangerous
Potential for leakage at the joint between the blood filters and tubing
Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL VESSEL CATH. INSERTION
Centurion Medical Products
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Y-Type Blood Set, Catalog Number 490293
B. Braun Medical
Class I - Dangerous
Potential for leakage at the joint between the blood filters and tubing
Centurion- OR2020 BASIN SET
Centurion Medical Products
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
Cardinal Health
Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Y-Type Blood Set, Catalog Number 490530
B. Braun Medical
Class I - Dangerous
Potential for leakage at the joint between the blood filters and tubing
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
Jjgc Industria E Comercio De Materials Dentarios Sa
Class I - Dangerous
The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".
Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
Centurion Medical Products
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Class I - Dangerous
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Centurion- Port Draw Kit KNV30 PORT DRAW KIT
Centurion Medical Products
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Centurion- LC145 STERILE NICU LINE CHANGE KIT
Centurion Medical Products
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Y-Type Blood Set, Catalog Number 490314
B. Braun Medical
Class I - Dangerous
Potential for leakage at the joint between the blood filters and tubing
Class I - Dangerous
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Class I - Dangerous
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
Cardinal Health
Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
Pacific Medical Group
Class I - Dangerous
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
Stryker Instruments Div. of Stryker
Class I - Dangerous
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
GORE¿ EXCLUDER¿ AAA Endoprosthesis
W. L. Gore & Associates
Class I - Dangerous
Firm has received reports of leading end catheter component separations.