Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total 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.
Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM
Centurion Medical Products
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
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
AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
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 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
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.
Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
Cook
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.
Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
Cardinal Health 200
Class I - Dangerous
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (Âŋ 0.2ÂŋC for Genius 2 and Âŋ 0.3ÂŋC for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2ÂŋC for Genius 2 or +0.3ÂŋC for Genius 3.
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
Genius 2 Tympanic Thermometer Private Label Item Code: 3069
Cardinal Health 200
Class I - Dangerous
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (Âŋ 0.2ÂŋC for Genius 2 and Âŋ 0.3ÂŋC for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2ÂŋC for Genius 2 or +0.3ÂŋC for Genius 3.
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