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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 261–280 of 788 recalls

Class IIITerminated

ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).

ECOLAB INC

The incorrect IFU was shipped with the product.

November 22, 2017 · DeviceView details →

Class IIITerminated

ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).

ECOLAB INC

The incorrect IFU was shipped with the product.

November 22, 2017 · DeviceView details →

Class IIITerminated

T/Pump temperature therapy pump, Models TP700 and TP700C

Stryker Medical Division of Stryker Corporation

The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications for Use statement.

November 7, 2017 · DeviceView details →

Class IIITerminated

Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Beckman Coulter Inc.

Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

November 6, 2017 · DeviceView details →

Class IIITerminated

UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Beckman Coulter Inc.

Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

November 6, 2017 · DeviceView details →

Class IIITerminated

Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Beckman Coulter Inc.

Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

November 6, 2017 · DeviceView details →

Class IIITerminated

OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036

Xintec Corp

It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.

October 29, 2017 · DeviceView details →

Class IIITerminated

STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K

Keystone Dental Inc

A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.

October 16, 2017 · DeviceView details →

Class IIITerminated

Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.

Degania Silicone, Ltd.

Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.

October 3, 2017 · DeviceView details →

Class IIITerminated

Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the presence or absence of drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process-is provided in the package labeling.

Ameditech Inc

Product was released to market without the adulteration strip included in the product.

September 30, 2017 · DeviceView details →

Class IIITerminated

AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212

PerkinElmer Life and Analytical Sciences, Wallac, OY

The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.

September 25, 2017 · DeviceView details →

Class IIITerminated

Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intrathecal space. The implanted system consists of an implantable infusion pump and an Ascenda catheter. The catheter connects to the pump at the catheter port and enters the intrathecal space.

Medtronic Neuromodulation

There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump.

September 21, 2017 · DeviceView details →

Class IIITerminated

Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.

Philips Electronics North America Corporation

Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM.

September 20, 2017 · DeviceView details →

Class IIITerminated

Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters. The Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights /7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner.

CooperVision Inc.

The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The primary blister reads Biofinity Multifocal Toric in error, and should read Biofinity XR Toric. The outer carton correctly reads Biofinity XR Toric.

September 1, 2017 · DeviceView details →

Class IIITerminated

Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)

Randox Laboratories

The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.

August 11, 2017 · DeviceView details →

Class IIITerminated

Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)

Randox Laboratories

The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.

August 11, 2017 · DeviceView details →

Class IIITerminated

Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

Ivoclar Vivadent, Inc.

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

August 3, 2017 · DeviceView details →

Class IIITerminated

Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502

Ivoclar Vivadent, Inc.

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

August 3, 2017 · DeviceView details →

Class IIITerminated

Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559

Ivoclar Vivadent, Inc.

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

August 3, 2017 · DeviceView details →

Class IIITerminated

Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503

Ivoclar Vivadent, Inc.

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

August 3, 2017 · DeviceView details →

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