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 3981–4000 of 39,430 recalls

Class IIOngoing

LABOR & DELIVERY PACK, Model Nos LLLD19H

American Contract Systems Inc

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

February 6, 2025 · DeviceView details →

Class IIOngoing

CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01

American Contract Systems Inc

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

February 6, 2025 · DeviceView details →

AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80

FDA Device Recalls

LABOR & DELIVERY PACK, Model Nos LLLD19H

CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01

AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80

GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08

C-SECTION PACK, Model Nos LLCS44F LLCS44F-01

DIAGNOSTIC NEURO IR TRAY , Model No WENE21

DELIVERY PACK , Model No SGDV22D-01 SGDV22E

OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I

HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02

LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B

LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

CYSTO , Model No SACY80R

DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01

LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02

VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03

CYSTO PACK , Model N. HKCY31A

BORN ON ARRIVAL KIT , Model No LLBN11B

URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03

GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03

C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04