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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 281–300 of 1,000 recalls

Class IIITerminated

EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430

Boston Scientific Corporation

May have been programmed with a less than optimal brightness setting resulting in a darker than desired image

March 16, 2021 · DeviceView details →

Class IIITerminated

KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.

Microbiologics Inc

Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.

February 24, 2021 · DeviceView details →

Class IIITerminated

KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.

Microbiologics Inc

Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.

February 24, 2021 · DeviceView details →

Class IIITerminated

Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.

OraSure Technologies, Inc.

Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.

February 5, 2021 · DeviceView details →

Class IIITerminated

Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps

OriGen Biomedical, Inc.

It was identified that tissue culture bags were incorrectly labeled as free of phthalates.

January 28, 2021 · DeviceView details →

Class IIITerminated

S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.

Medline Industries Inc

Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.

January 15, 2021 · DeviceView details →

Class IIITerminated

Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler has a "baseboard" unit with firmware and associated software component that control motorized movements of the optical filter carriage used for PCR detection.

Biomeme, Inc.

Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.

January 5, 2021 · DeviceView details →

Class IIICompleted

HAMILTON-H900 Humidifier, Models: 950001, 950004

Hamilton Medical AG

When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.

January 5, 2021 · DeviceView details →

Class IIITerminated

Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.

Fujifilm Medical Systems U.S.A., Inc.

FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing.

December 22, 2020 · DeviceView details →

Class IIITerminated

KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)

Microbiologics Inc

The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022.

December 16, 2020 · DeviceView details →

Class IIITerminated

AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075

Applied Medical Technology Inc

The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.

November 10, 2020 · DeviceView details →

Class IIIOngoing

VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

Ortho Clinical Diagnostics Inc

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

October 16, 2020 · DeviceView details →

Class IIITerminated

Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional.

Talladium Inc

Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 (98x20mm). However, the item inside the box was Part no. 4302-B1 (95x20mm). An incorrect label may result in compatibility issues when setting up the disc with milling machine fixtures due to size variation.

October 9, 2020 · DeviceView details →

Class IIITerminated

KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)

Microbiologics Inc

The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.

October 8, 2020 · DeviceView details →

Class IIITerminated

Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN

Steris Corporation

Potential for cleaning solution intrusion into endoscope

October 7, 2020 · DeviceView details →

Class IIITerminated

Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499

Hardy Diagnostics

Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10

October 6, 2020 · DeviceView details →

Class IIITerminated

XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Number: M697X0980107STR1 Mat.: CP Ti Grade 4, Ref: X098-0108-STR DI Number: M697X0980108STR1 Mat.: CP Ti Grade 5, Ref: X098-0109-STR DI Number: M697X0980109STR1 Mat.: CP Ti Grade 6, Ref: X098-0110-STR DI Number: M697X0980110STR1 Mat.: CP Ti Grade 7, Ref: X098-0111-STR DI Number: M697X0980111STR1 Mat.: CP Ti Grade 8, Ref: X098-0112-STR DI Number: M697X0980112STR1 Mat.: CP Ti Grade 9, Ref: X098-0205-STR DI Number: M697X0980205STR1 Mat.: CP Ti Grade 10, Ref: X098-0206-STR DI Number: M697X0980206STR1 Mat.: CP Ti Grade 11, Ref: X098-0207-STR DI Number: M697X0980207STR1 Mat.: CP Ti Grade 12, Ref: X098-0208-STR DI Number: M697X0980208STR1 Mat.: CP Ti Grade 13, Ref: X098-0209-STR DI Number: M697X0980209STR1 Mat.: CP Ti Grade 14, Ref: X098-0210-STR DI Number: M697X0980210STR1 Mat.: CP Ti Grade 15, Ref: X098-0211-STR DI Number: M697X0980211STR1 Mat.: CP Ti Grade 16, Ref: X098-0212-STR DI Number: M697X0980212STR1 Mat.: CP Ti Grade 17, Ref: X098-0305-STR DI Number: M697X0980305STR1 Mat.: CP Ti Grade 18, Ref: X098-0306-STR DI Number: M697X0980306STR1 Mat.: CP Ti Grade 19, Ref: X098-0307-STR DI Number: M697X0980307STR1 Mat.: CP Ti Grade 20, Ref: X098-0308-STR DI Number: M697X0980308STR1 Mat.: CP Ti Grade 21, Ref: X098-0309-STR DI Number: M697X0980309STR1 Mat.: CP Ti Grade 22, Ref: X098-0310-STR DI Number: M697X0980310STR1 Mat.: CP Ti Grade 23, Ref: X098-0311-STR DI Number: M697X0980311STR1 Mat.: CP Ti Grade 24, Ref: X098-0312-STR DI Number: M697X0980312STR1 Mat.: CP Ti Grade 25

XTANT Medical

Cervical Implants contain a label that incorrectly identifies the grade of titanium used.

September 30, 2020 · 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 IIITerminated

END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →

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