Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Surgical Instruments
π₯ Medical Devices β’ 6,839 recalls
NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.
Dutch Ophthalmic USA
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Bard Peripheral Vascular
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
There is a potential that 7F sheaths are packaged as 10F sheaths.
There is a potential that 7F sheaths are packaged as 10F sheaths.
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
Bard Peripheral Vascular
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
Stryker Medical Division of Stryker
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in injury
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
Dutch Ophthalmic USA
Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281.B1D06
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Axonics Modulation Technologies
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Marketed without a 510K
Marketed without a 510K
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Marketed without a 510K
Marketed without a 510K