FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 4241–4260 of 39,430 recalls

Class IIOngoing

Baxter Solution Set with Duo-Vent Spike, REF 2R8404

Baxter Healthcare Corporation

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

December 20, 2024 · DeviceView details →

Class IIOngoing

AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690

Boston Scientific Corporation

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

December 20, 2024 · DeviceView details →

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

FDA Device Recalls

Baxter Solution Set with Duo-Vent Spike, REF 2R8404

AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690

Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570

Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520

AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750

PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.

AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660

Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A

KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123

8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401

KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123

8MM,MEGA SUTURECUT ND,IS4000 REF 471309

8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006

8MM,PROGRASP FORCEPS,IS4000 REF 471093

KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE