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© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA sources before acting

  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 IITerminated

RayStation 9B SP1. For radiation treatment planning.

RAYSEARCH LABORATORIES AB

An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.

June 1, 2022 · DeviceView details →
Class IITerminated

NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

Fresenius Medical Care Holdings, Inc.

The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.

June 1, 2022 · DeviceView details →
Class IITerminated

OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.

Ossur Americas

Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot.

May 30, 2022 · DeviceView details →
Class IITerminated

SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX550S (Carton) - 550 Micron Single Use Fiber Model # Labeled TFL-FBX200S (Carton) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX365S (Pouch) - 200 Micron Single Use Fiber

Olympus Corporation of the Americas

Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.

May 26, 2022 · DeviceView details →
Class IITerminated

Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System

Siemens Medical Solutions USA, Inc

It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only be reactivated by a field service engineer.

May 24, 2022 · DeviceView details →
Class IITerminated

regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.

ROi CPS LLC

A nonsterile component was packaged in a sterile convenience kit.

May 20, 2022 · DeviceView details →
Class IITerminated

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

Chromsystems Instruments & Chemicals GmbH

Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.

May 19, 2022 · DeviceView details →
Class IITerminated

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II

Chromsystems Instruments & Chemicals GmbH

Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.

May 19, 2022 · DeviceView details →
Class IITerminated

Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521

Siemens Healthcare Diagnostics, Inc.

Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction

May 18, 2022 · DeviceView details →
Class IITerminated

Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C

Siemens Healthcare Diagnostics, Inc.

Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction

May 18, 2022 · DeviceView details →
Class IITerminated

#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED

Baxter Healthcare Corporation

Packaging error.

May 17, 2022 · DeviceView details →
Class IITerminated

Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

Volcano Corp

Due to a potential failed sterilization process.

May 16, 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

Arrow Three-Lumen CVC

ARROW INTERNATIONAL Inc.

Gravity flow rates on the affected product lidstock are incorrect.

May 5, 2022 · DeviceView details →
Class IITerminated

Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

Fresenius Medical Care Holdings, Inc.

Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

May 4, 2022 · DeviceView details →
Class IITerminated

PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

MicroPort Orthopedics Inc.

One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.

May 4, 2022 · DeviceView details →
Class IITerminated

Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

ROi CPS LLC

Potential for the tip of the electrode to detach during use.

May 3, 2022 · DeviceView details →
Class IITerminated

regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

ROi CPS LLC

Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.

May 3, 2022 · DeviceView details →
Class IITerminated

INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta

Maquet Cardiovascular, LLC

Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm

April 29, 2022 · DeviceView details →
Class IITerminated

FIRMap" Catheter, 60mm Basket

Abbott

Incorrect product labeling.

April 28, 2022 · DeviceView details →
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