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 1–3 of 3 recalls for “Mislabeling”

Class ITerminated

DeRoyal Angio Cath Removal Tray, REF 89-9936.02

DeRoyal Industries Inc

DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine

May 14, 2021 · DeviceView details →

Class ITerminated

DeRoyal Heart Cath Procedure Pack, REF 89-6556.08

DeRoyal Industries Inc

DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine

May 14, 2021 · DeviceView details →

DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine

FDA Device Recalls

DeRoyal Angio Cath Removal Tray, REF 89-9936.02

DeRoyal Heart Cath Procedure Pack, REF 89-6556.08

DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06