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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 121–140 of 1,000 recalls

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 →
Class ITerminated

DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06

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

LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098

Magellan Diagnostics, Inc.

Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.

May 7, 2021 · DeviceView details →
Class ITerminated

LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004

Magellan Diagnostics, Inc.

Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.

May 7, 2021 · DeviceView details →
Class ITerminated

LeadCare II Blood Lead Test Kit Catalog Number 70-6762

Magellan Diagnostics, Inc.

Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.

May 7, 2021 · DeviceView details →
Class ITerminated

Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are not defined as they are not intended for final use.

Medtronic Vascular

The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.

May 4, 2021 · DeviceView details →
Class ITerminated

Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent

Quidel Corporation

In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users.

April 27, 2021 · DeviceView details →
Class ITerminated

FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.

Avid Medical, Inc.

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.

April 9, 2021 · DeviceView details →
Class ITerminated

DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.

Avid Medical, Inc.

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.

April 9, 2021 · DeviceView details →
Class ITerminated

Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B

Medical Action Industries, Inc. 306

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

April 9, 2021 · DeviceView details →
Class ITerminated

Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420

Medical Action Industries, Inc. 306

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

April 9, 2021 · DeviceView details →
Class ITerminated

ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04

Avid Medical, Inc.

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.

April 9, 2021 · DeviceView details →
Class ITerminated

Kit: Blood Culture. MAI Kit Part Number: 80315D

Medical Action Industries, Inc. 306

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

April 9, 2021 · DeviceView details →
Class ITerminated

FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03

Avid Medical, Inc.

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.

April 9, 2021 · DeviceView details →
Class ITerminated

Kit: Midline Insertion DA. MAI Kit Part Number: 77981B

Medical Action Industries, Inc. 306

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

April 9, 2021 · DeviceView details →
Class ITerminated

Kit: Injection REVIEW MAI Kit Part Number: 74736

Medical Action Industries, Inc. 306

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

April 9, 2021 · DeviceView details →
Class ITerminated

Kit: Blood Culture MAI Kit Part Number: 80076

Medical Action Industries, Inc. 306

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

April 9, 2021 · DeviceView details →
Class ITerminated

Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part

STEP-HAR MEDICAL LLC

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

February 26, 2021 · DeviceView details →
Class ITerminated

Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

BioMedical Equipment Service Co (BMES)

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

February 25, 2021 · DeviceView details →
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