Medical DeviceJul 16, 2025
Preat recall — FDA Z-2107-2025
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Class IIFDA: OngoingPreat Corp
21,924medical device recall records
2,160FDA Class I records
8firms with 5+ records
MEDLINE INDUSTRIES, LP…730 records
Database records
Records — page 126
21,924 detailed records are currently available in this category.
Medical DeviceJul 16, 2025
Alcon Laboratories, Inc. Constellation Vision System Combined Procedure Pak recall — FDA Z-2109-2025
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the…
Class IIFDA: OngoingAlcon Research LLC
Medical DeviceJul 16, 2025
FEM-FLEX II Femoral Arterial Cannula recall — FDA Z-2082-2025
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Class IFDA: OngoingEdwards Lifesciences, LLC
Medical DeviceJul 16, 2025
FEM-FLEXII Femoral Arterial Cannula recall — FDA Z-2085-2025
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Class IFDA: OngoingEdwards Lifesciences, LLC
Medical DeviceJul 16, 2025
Hummingbird Stimulated EMG Kit with Hummingbird recall — FDA Z-2100-2025
Product packaging contains the wrong part number and kit contents.
Class IIFDA: OngoingNeurovision Medical Products Inc.
Medical DeviceJul 16, 2025
Alcon Laboratories, Inc. Custom Pak recall — FDA Z-2110-2025
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the…
Class IIFDA: OngoingAlcon Research LLC
Medical DeviceJul 16, 2025
STRATASYS TrueDent Magenta, TDM130, Model No recall — FDA Z-2092-2025
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and…
Class IIIFDA: CompletedSTRATASYS LTD
Medical DeviceJul 16, 2025
STRATASYS TrueDent White, TDM110, Model No recall — FDA Z-2094-2025
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and…
Class IIIFDA: CompletedSTRATASYS LTD
Medical DeviceJul 16, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Varicam, Millennium VG, Millennium VG Hawkeye recall — FDA Z-2098-2025
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may…
Class IIFDA: OngoingGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Medical DeviceJul 16, 2025
Optisite Arterial Cannula recall — FDA Z-2081-2025
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Class IFDA: OngoingEdwards Lifesciences, LLC
Medical DeviceJul 9, 2025
Philips eL18-4 EMT Transducer recall — FDA Z-2053-2025
Ultrasound transducer devices were refurbished beyond their useful life.
Class IIFDA: OngoingPhilips Ultrasound, Inc.
Medical DeviceJul 9, 2025
Becton, Dickinson and Company, BD Bio Sciences REF: 666289 , BD FACS, 7-Color Setup Beads recall — FDA Z-2079-2025
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
Class IIFDA: OngoingBecton, Dickinson and Company, BD Bio Sciences
Medical DeviceJul 9, 2025
Philips C9-5EC Transducer recall — FDA Z-2051-2025
Ultrasound transducer devices were refurbished beyond their useful life.
Class IIFDA: OngoingPhilips Ultrasound, Inc.
Medical DeviceJul 9, 2025
Change Healthcare Cardiology Hemodynamics Software recall — FDA Z-2072-2025
Due to complaints, software update may cause software to unexpectedly shutdown.
Class IIFDA: OngoingCHANGE HEALTHCARE CANADA COMPANY
Medical DeviceJul 9, 2025
Maquet Critical Care AB Servo-u Ventilator System recall — FDA Z-2013-2025
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active…
Class IFDA: OngoingMaquet Critical Care AB
Medical DeviceJul 9, 2025
CORIN MEDICAL Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117 recall — FDA Z-2069-2025
Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
Class IIFDA: OngoingCORIN MEDICAL, LTD.
Medical DeviceJul 9, 2025
Philips eL18-4 Transducer recall — FDA Z-2052-2025
Ultrasound transducer devices were refurbished beyond their useful life.
Class IIFDA: OngoingPhilips Ultrasound, Inc.
Medical DeviceJul 9, 2025
Philips Respironics BiPAP A40 Ventilator recall — FDA Z-2037-2025
This device does not indicate for use in patients with respiratory failure.
Class IFDA: OngoingPhilips Respironics, Inc.
Medical DeviceJul 9, 2025
Philips C5-2 Transducer recall — FDA Z-2050-2025
Ultrasound transducer devices were refurbished beyond their useful life.
Class IIFDA: OngoingPhilips Ultrasound, Inc.
Medical DeviceJul 9, 2025
Philips L12-3 Transducer recall — FDA Z-2054-2025
Ultrasound transducer devices were refurbished beyond their useful life.
Class IIFDA: OngoingPhilips Ultrasound, Inc.
Medical DeviceJul 9, 2025
Philips X6-1 Transducer recall — FDA Z-2065-2025
Ultrasound transducer devices were refurbished beyond their useful life.
Class IIFDA: OngoingPhilips Ultrasound, Inc.
Medical DeviceJul 9, 2025
HemoCue AB The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue recall — FDA Z-2070-2025
Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been…
Class IIFDA: OngoingHemoCue AB
Medical DeviceJul 9, 2025
Philips X8-2t Transducer recall — FDA Z-2067-2025
Ultrasound transducer devices were refurbished beyond their useful life.
Class IIFDA: OngoingPhilips Ultrasound, Inc.
Medical DeviceJul 9, 2025
Philips V6-2 Transducer recall — FDA Z-2062-2025
Ultrasound transducer devices were refurbished beyond their useful life.
Class IIFDA: OngoingPhilips Ultrasound, 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.