Adept Medical Otological Ventilation Tube - T-Tube 6mm - Silicone recall — FDA Z-0963-2025
Lack of 510(k) clearance.
Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
21,924 detailed records are currently available in this category.
Lack of 510(k) clearance.
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation…
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Potential for hole in package compromising sterility of the medical kit.
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA)…
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA)…
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation…
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal,…
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
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.
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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.