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.
21,006 detailed records are currently available in this category.
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or…
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or…
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience…
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new…
Overheating of the 115V CPU board may cause the device to shut down.
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault…
Overheating of the 115V CPU board may cause the device to shut down.
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new…
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may…
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
The module did not undergo electrical safety tests and functional tests during production.
Potential for electrical discharge from unit when unplugged.
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if…
Due to an increase rate of balloon pinhole defects.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced…
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Firmware issue potentially leading to loss of geometry movements.
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced…
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced…
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms,…
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.
