Cook Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter recall — FDA Z-2222-2024
Product labels state the incorrect expiration dates that extends beyond their true expiration date
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.
22,877 detailed records are currently available in this category.
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Potential for coils to heat up and harm patients (burn).
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents…
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray…
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions…
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray…
The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B…
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create…
Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User…
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
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.