FDA Device Recalls

Class IOngoing

Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F

Windstone Medical Packaging, Inc.

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.

April 2, 2026 · DeviceView details →

QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.

Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.

TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis

Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy.

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.

One Step K in vitro diagnostic test REF: 81A4

Uric Acid in vitro diagnostic test REF: 31H0P

Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F

QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

One Step P in vitro diagnostic test REF: 8194

One Step pH in vitro diagnostic test REF: 31I4P