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FDA Recalls
›Device Recalls

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 181–200 of 1,000 recalls

Class IITerminated

Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.

ROi CPS LLC

Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

June 3, 2022 · DeviceView details →

Class IITerminated

Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.

ROi CPS LLC

Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

June 3, 2022 · DeviceView details →

Class IITerminated

DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.

CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.

One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates

June 2, 2022 · DeviceView details →

Class ITerminated

GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.

GE Healthcare, LLC

There is a potential reversal of the O2 and air cylinder pressure transducer connections.

June 1, 2022 · DeviceView details →

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 IIITerminated

NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006

Synapse Biomedical Inc

Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).

May 31, 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 IIITerminated

KWIK-STIK" plus: Clostridium perfringens

Microbiologics Inc

Labeling error.

May 6, 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 →

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