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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 281–300 of 786 recalls

Class IIITerminated

Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine

Ameditech Inc

The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.

June 26, 2017 · DeviceView details →
Class IIITerminated

BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD Phoenix" system, which performs identification and susceptibility testing

Becton Dickinson & Co.

Potential unexpected movement of robot arm

June 1, 2017 · DeviceView details →
Class IIITerminated

PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.

PerkinElmer Health Sciences, Inc.

PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.

May 31, 2017 · DeviceView details →
Class IIITerminated

DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

Euro Diagnostica AB

FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date.

May 22, 2017 · DeviceView details →
Class IIITerminated

Beekley Medical 0-SPOT Mammography Skin Markers REF 652

Beekley Corporation

Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels

May 8, 2017 · DeviceView details →
Class IIITerminated

Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.

Randox Laboratories

According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product. As control results will be outside of the quoted range this may result in a delay in reporting the sample test results. However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice

April 27, 2017 · DeviceView details →
Class IIITerminated

Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.

Teleflex Medical

Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.

March 29, 2017 · DeviceView details →
Class IIITerminated

LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.

Microbiologics Inc

Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

March 2, 2017 · DeviceView details →
Class IIITerminated

KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.

Microbiologics Inc

Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

March 2, 2017 · DeviceView details →
Class IIITerminated

BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.

Philips Medical Systems (Cleveland) Inc

The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

February 24, 2017 · DeviceView details →
Class IIITerminated

ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c

Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042.

February 23, 2017 · DeviceView details →
Class IIITerminated

AIA-PACK TPOAb CONTROL SET

Tosoh Bioscience, Inc.

The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.

February 8, 2017 · DeviceView details →
Class IIITerminated

AIA-PACK TgAb CONTROL SET

Tosoh Bioscience, Inc.

The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.

February 8, 2017 · DeviceView details →
Class IIITerminated

Daavlin Aquex (DAAV1000)

Hidrex GmbH

The device was reclassified from a class III device to a class II device and there are new documentation requirements.

January 30, 2017 · DeviceView details →
Class IIITerminated

Hidrex USA DVP1000

Hidrex GmbH

The device was reclassified from a class III device to a class II device and there are new documentation requirements.

January 30, 2017 · DeviceView details →
Class IIITerminated

Hidrex USA DP450

Hidrex GmbH

The device was reclassified from a class III device to a class II device and there are new documentation requirements.

January 30, 2017 · DeviceView details →
Class IIITerminated

DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

DeRoyal Industries Inc

DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products.

January 25, 2017 · DeviceView details →
Class IIITerminated

The UNI-CP System; Model Number: 330230SND.

Integra LifeSciences Corp.

The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.

January 25, 2017 · DeviceView details →
Class IIITerminated

SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

DeRoyal Industries Inc

DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products.

January 25, 2017 · DeviceView details →
Class IIITerminated

AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.

Applied Medical Technology Inc

Expired expiration dates are listed on the pouches.

January 19, 2017 · DeviceView details →
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