Medical DeviceApr 21, 2021
Stryker recall — FDA Z-1428-2021
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
Class IIFDA: TerminatedStryker Corporation
24,725medical device recall records
2,223FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.757 records
Database records
Records — page 513
24,725 detailed records are currently available in this category.
Medical DeviceApr 21, 2021
Siemens Healthcare Diagnostics ADVIA 2120i (RoHS) with Single Aspirate Autosampler recall — FDA Z-1404-2021
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 21, 2021
Centinel Spine Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in recall — FDA Z-1406-2021
Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is…
Class IIFDA: TerminatedCentinel Spine, Inc.
Medical DeviceApr 21, 2021
Siemens Healthcare Diagnostics ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS recall — FDA Z-1397-2021
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 21, 2021
Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm recall — FDA Z-1384-2021
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the…
Class IIFDA: TerminatedCovidien, LP
Medical DeviceApr 21, 2021
Krishe Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50 recall — FDA Z-1420-2021
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Class IIFDA: TerminatedKrishe Inc.
Medical DeviceApr 21, 2021
EOS Imaging The EOSedge system may acquire two simultaneous orthogonal planar images for a recall — FDA Z-1415-2021
Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).
Class IIFDA: TerminatedEOS Imaging
Medical DeviceApr 21, 2021
Siemens Healthcare Diagnostics ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US recall — FDA Z-1389-2021
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 21, 2021
Siemens Healthcare Diagnostics ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) recall — FDA Z-1400-2021
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 21, 2021
Arthrex Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in recall — FDA Z-1380-2021
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
Class IIFDA: TerminatedArthrex, Inc.
Medical DeviceApr 21, 2021
Boston Scientific MAMBA Microcatheter recall — FDA Z-1430-2021
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceApr 21, 2021
Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) recall — FDA Z-1424-2021
When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
Class IIFDA: OngoingRemel Inc.
Medical DeviceApr 21, 2021
Becton Dickinson & Co BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for recall — FDA Z-1416-2021
BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty…
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceApr 21, 2021
Siemens Healthcare Diagnostics ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US recall — FDA Z-1391-2021
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 21, 2021
Siemens Healthcare Diagnostics ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US recall — FDA Z-1388-2021
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 21, 2021
Siemens Healthcare Diagnostics ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US recall — FDA Z-1392-2021
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 21, 2021
Siemens Healthcare Diagnostics ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US recall — FDA Z-1387-2021
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 14, 2021
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult recall — FDA Z-1366-2021
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
Class IIFDA: TerminatedSharp Medical Products
Medical DeviceApr 14, 2021
Heartware Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA recall — FDA Z-1336-2021
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller…
Class IFDA: OngoingHeartware, Inc.
Medical DeviceApr 14, 2021
Beckman Coulter MicroScan WalkAway-40 plus Instrument recall — FDA Z-1370-2021
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC)…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceApr 14, 2021
Beckman Coulter MicroScan WalkAway-40 plus Reconditioned Instrument recall — FDA Z-1372-2021
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC)…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceApr 14, 2021
ROi CPS Regard, Item Number 830067009, custom cardiovascular procedure kit recall — FDA Z-1376-2021
ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product…
Class IIFDA: OngoingROi CPS LLC
Medical DeviceApr 14, 2021
Heartware Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE recall — FDA Z-1340-2021
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller…
Class IFDA: OngoingHeartware, Inc.
Medical DeviceApr 14, 2021
Fenwal Amicus Exchange Kit - Product Usage: intended for use in the collection of blood recall — FDA Z-1344-2021
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood…
Class IIFDA: TerminatedFenwal Inc.
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.