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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 1–20 of 43 recalls for “Mislabeling”

Class IITerminated

ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.

ARROW INTERNATIONAL Inc.

Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).

September 14, 2022 · DeviceView details →
Class IITerminated

Alcon Clareon IOL with AutonoMe Delivery System

Alcon Laboratories Ireland, Ltd

Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.

May 11, 2022 · DeviceView details →
Class IITerminated

REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder

Stryker Sustainability Solutions

Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.

January 21, 2022 · DeviceView details →
Class IITerminated

Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

Maquet Cardiovascular, LLC

There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.

December 1, 2021 · DeviceView details →
Class IITerminated

DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145

Cardiovascular Systems Inc

There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.

July 21, 2021 · DeviceView details →
Class IITerminated

STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO

Cardiovascular Systems Inc

There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.

July 21, 2021 · DeviceView details →
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 IIITerminated

AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260). For cochlear implant.

Advanced Bionics, LLC

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

September 26, 2020 · DeviceView details →
Class IIITerminated

AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.

Advanced Bionics, LLC

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

September 26, 2020 · DeviceView details →
Class IITerminated

Luer Lock Set - Catalog # MPC-125, for IV administration sets.

Molded Products Inc

Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrectly labeled as Molded Products Male to Male Luer Adapters, Catalog # MPC-150.

June 10, 2019 · DeviceView details →
Class IITerminated

OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

Matrix Surgical Holdings, LLC

Product mislabeling.

January 30, 2019 · DeviceView details →
Class IITerminated

OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

Matrix Surgical Holdings, LLC

Product mislabeling.

January 30, 2019 · DeviceView details →
Class IITerminated

URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with CK20 is a cocktail of mouse monoclonal and rabbit monoclonal antibodies that is intended for laboratory use in the qualitative identification of CD44, p53 and CK20 proteins by immunohistochemistry (IHC) in formalin-fixed paraffin-embedded (FFPE) human tissues, primarily for bladder cancer characterization. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient s clinical history and other diagnostic tests by a qualified pathologist. The URO-3 Triple Stain is an adjunct immunohistochemistry test to assist a qualified pathologist in differentiating urothelial reactive atypia from CIS (carcinoma in situ) in suspected bladder lesions. The URO-3 staining pattern will be used as supporting data along with morphological and patient history context for the qualified pathologist to render a diagnosis.

Biocare Medical, LLC

Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.

March 15, 2018 · DeviceView details →
Class IITerminated

HEMASHIELD Knitted Double Velour Cardiovascular Fabric

GETINGE US SALES LLC

A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).

January 3, 2018 · DeviceView details →
Class IITerminated

Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.

Ortho Solutions Inc

There is a material mislabeling of the AFN End Cap.

April 19, 2017 · DeviceView details →
Class IITerminated

MicroAire K-Wires

MicroAire Surgical Instruments, LLC

Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).

February 21, 2017 · DeviceView details →
Class IITerminated

OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right

Matrix Surgical Holdings, LLC

Mislabeling. The packaging labeled as left mandible contained a right mandible.

January 25, 2017 · DeviceView details →
Class IITerminated

Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies

Zimmer Biomet, Inc.

labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.

December 16, 2016 · DeviceView details →
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