FDA Device Recalls

Class IIOngoing

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

Waldemar Link GmbH & Co. KG (Mfg Site)

The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.

July 6, 2026 · DeviceView details →

TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799

FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.

Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.

Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.

Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.

Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US

Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095

Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);

Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.

5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm

Cardiac Workstation 5000. Product Number: 860439.

Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm