Medical DeviceFeb 9, 2022
FEMSelect The EnPlace is a single use trans-vaginal pelvic floor repair system which enables recall — FDA Z-0556-2022
Certain lots may not have been packaged wth the Channel Tube Limiter.
Class IIFDA: OngoingFEMSelect Ltd
24,239medical device recall records
2,205FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.751 records
Database records
Records — page 453
24,239 detailed records are currently available in this category.
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0541-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0537-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
Microbiologics KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF recall — FDA Z-0544-2022
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Class IIIFDA: TerminatedMicrobiologics Inc.
Medical DeviceFeb 9, 2022
LivaNova USA Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303 recall — FDA Z-0532-2022
A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the…
Class IIFDA: TerminatedLivaNova USA, Inc.
Medical DeviceFeb 9, 2022
Microbiologics KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U recall — FDA Z-0546-2022
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…
Class IIIFDA: TerminatedMicrobiologics Inc.
Medical DeviceFeb 9, 2022
Olympus Corporation of the Americas Spiration Valve System (SVS) Valve in Cartridge -A recall — FDA Z-0551-2022
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0539-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
Philips eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3 recall — FDA Z-0549-2022
eCareManager (eCM) Sentry Score software not approved for use
Class IIFDA: TerminatedPhilips North America LLC
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0538-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
Baxter Spectrum IQ Infusion Pumps, Product code 3570009 recall — FDA Z-0529-2022
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceFeb 9, 2022
Microbiologics KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P recall — FDA Z-0543-2022
Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
Class IIIFDA: TerminatedMicrobiologics Inc.
Medical DeviceFeb 9, 2022
Covidien Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon recall — FDA Z-0557-2022
The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the…
Class IIFDA: OngoingCovidien LLC
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0536-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0535-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0540-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0542-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
Siemens Medical Solutions USA ACUSON Sequoia Ultrasound Imaging System with Software Version recall — FDA Z-0547-2022
Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceFeb 9, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01 recall — FDA Z-0558-2022
The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European…
Class IIFDA: TerminatedCELLTRION USA Inc.
Medical DeviceFeb 9, 2022
Immuno-Mycologics CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the recall — FDA Z-0545-2022
The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number…
Class IIFDA: TerminatedImmuno-Mycologics, Inc.
Medical DeviceFeb 9, 2022
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF recall — FDA Z-0555-2022
The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
Class IIFDA: OngoingYoung Dental Mfg Co I LLC
Medical DeviceFeb 9, 2022
Luminex ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 recall — FDA Z-0553-2022
Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due…
Class IIFDA: TerminatedLuminex Corporation
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0534-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
Abiomed OXY-1 System, Model Number 001-0500-001 recall — FDA Z-0550-2022
The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy…
Class IFDA: TerminatedAbiomed, 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.