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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 901–920 of 1,000 recalls

Class IIITerminated

IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.

Alere San Diego, Inc.

Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.

February 26, 2013 · DeviceView details →
Class IIITerminated

Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Cooper Surgical, Inc.

Pessary mislabeled outer package may not reflect the size of the product contained in the package

February 26, 2013 · Device
View details →
Class IIITerminated

Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Cooper Surgical, Inc.

Pessary mislabeled outer package may not reflect the size of the product contained in the package

February 26, 2013 · DeviceView details →
Class IIITerminated

Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Cooper Surgical, Inc.

Pessary mislabeled outer package may not reflect the size of the product contained in the package

February 26, 2013 · DeviceView details →
Class IIITerminated

Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Cooper Surgical, Inc.

Pessary mislabeled outer package may not reflect the size of the product contained in the package

February 26, 2013 · DeviceView details →
Class IIITerminated

Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Cooper Surgical, Inc.

Pessary mislabeled outer package may not reflect the size of the product contained in the package

February 26, 2013 · DeviceView details →
Class IIITerminated

Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Cooper Surgical, Inc.

Pessary mislabeled outer package may not reflect the size of the product contained in the package

February 26, 2013 · DeviceView details →
Class IIITerminated

Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Cooper Surgical, Inc.

Pessary mislabeled outer package may not reflect the size of the product contained in the package

February 26, 2013 · DeviceView details →
Class IIITerminated

Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Cooper Surgical, Inc.

Pessary mislabeled outer package may not reflect the size of the product contained in the package

February 26, 2013 · DeviceView details →
Class IIITerminated

Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number: MXPCONDS05 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Cooper Surgical, Inc.

Pessary mislabeled outer package may not reflect the size of the product contained in the package

February 26, 2013 · DeviceView details →
Class IIITerminated

Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing characterized positive and negative controls intended for use in qualitative procedures as external quality control material for the Remel Xpect Flu A&B test kit.

Remel Inc

Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.

February 19, 2013 · DeviceView details →
Class IIITerminated

ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.

Horiba Instruments, Inc dba Horiba Medical

Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.

February 15, 2013 · DeviceView details →
Class IIITerminated

BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.

Becton Dickinson & Company

The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags which are incorrectly labeled as Catalog #364953. BD advises any Customer who purchased this Kit that the Tube in this Kit is not a C&S tube. If a Customer relies solely on the polybag labeling and uses the Tube inside the Kit for the purpose of collecting urine for culture and sensitivity, it is possible

February 14, 2013 · DeviceView details →
Class IIITerminated

Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.

Ultradent Products, Inc.

Orthodontic brackets distributed was incorrectly labeled.

February 8, 2013 · DeviceView details →
Class IIITerminated

Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.

Ultradent Products, Inc.

Incorrect packaging of regular set and fast set cartridges.

February 4, 2013 · DeviceView details →
Class IIITerminated

Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

Ultradent Products, Inc.

Incorrect packaging of regular set and fast set cartridges.

February 4, 2013 · DeviceView details →
Class IIITerminated

D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone

Linvatec Corp. dba ConMed Linvatec

The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.

January 24, 2013 · DeviceView details →
Class IIITerminated

D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone

Linvatec Corp. dba ConMed Linvatec

The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.

January 24, 2013 · DeviceView details →
Class IIITerminated

Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

Bion Enterprises Ltd

Affected products have a labeled expiration date of one year too long.

January 23, 2013 · DeviceView details →
Class IIITerminated

Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

Bion Enterprises Ltd

Affected products have a labeled expiration date of one year too long.

January 23, 2013 · DeviceView details →
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