Medical Device Recalls since April 14, 2025

PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter

Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-DRW, LT588-DW, LT761-DRW, LT761-DRWZ, LT762-DRW, LT777-DW, LT788-DW, LT961-DRW, LT961-DRWZ, LT962-DRW, LT967-DW, LT977-DW, LT988-DW, TST1763-DRW, TST1764-DRW, TST663-DRW, TST963-DRW, TST964-DRW, VA861-DRW, VA861-DRWZ, VA862-DRW

Atellica CH 930 Analyzer

Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.

BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.

EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1

EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665

Synchromed II programmable pump, Model numbers 8637-20 and 8637-40

Giraffe OmniBed Carestation, Giraffe OmniBed Carestation CS1

Giraffe Incubator

Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1

Giraffe OmniBed

XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.

PANTERA Proximal Humerus Fracture Plate System

TLC-2000 Therapeutic Medical Laser System Laser Probe

Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20¿. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.

Bard Peripheral Vascular Inc - Bard Access Systems PowerPort isp M.R.I. Implantable Port - Class 2 Recall

GN Hearing A/S - BehindtheEar hearing aids - Class 2 Recall

Siemens Healthcare Diagnostics, Inc. - Atellica CH 930 Analyzer - Class 2 Recall

Steris Corporation - Class 2 Recall

Stryker Instruments Div. of Stryker Corporation - Color Cuff Disposable Tourniquet Cuff - Class 2 Recall

Brasseler USA I Lp - BRASSELER Twist Drill Quick Connect - Class 2 Recall

Stryker Instruments Div. of Stryker Corporation - Color Cuff Disposable Tourniquet Cuff - Class 2 Recall

NDDd Medical Technologies, Inc. - EasyOne Pro Respiratory Analysis System - Class 2 Recall

NDDd Medical Technologies, Inc. - EasyOne Pro Respiratory Analysis System - Class 2 Recall

Zimmer Biomet, Inc. - Zimmer Biomet Intramedullary Bone Saw - Class 2 Recall

Zimmer Biomet, Inc. - Zimmer Biomet Intramedullary Bone Saw - Class 2 Recall

Medtronic Neuromodulation - Synchromed II programmable pump - Class 1 Recall

GE Healthcare, LLC - Giraffe OmniBed Carestation, Giraffe OmniBed Carestation CS1 - Class 1 Recall

GE Healthcare, LLC - Giraffe Incubator - Class 1 Recall

GE Healthcare, LLC - Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 - Class 1 Recall

GE Healthcare, LLC - Giraffe OmniBed - Class 1 Recall

Allergan PLC - Xen Glaucoma Treatment System - Class 2 Recall

Toby Orthopaedics, Inc. - PANTERA Proximal Humerus Fracture Plate System - Class 2 Recall

Theralase Inc. - Class 2 Recall

Miami Device Solutions, LLC. - Proximal Humerus Plate, 8 holes, Right - Class 2 Recall