Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
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
Class I - Dangerous
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
Class I - Dangerous
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Class I - Dangerous
There is a potential that 7F sheaths are packaged as 10F sheaths.
Class I - Dangerous
There is a potential that 7F sheaths are packaged as 10F sheaths.
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Class I - Dangerous
Marketed without a 510K
Class I - Dangerous
Marketed without a 510K
Class I - Dangerous
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Class I - Dangerous
Marketed without a 510K
Class I - Dangerous
Marketed without a 510K
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
Owen Mumford USA
Class I - Dangerous
Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.
Class I - Dangerous
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
Class I - Dangerous
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
Class I - Dangerous
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.