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.
26,155 detailed records are currently available in this category.
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS…
One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus…
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
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.
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.
