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.
26,628 detailed records are currently available in this category.
Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the…
Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date…
Patient monitors may restart due to network overload caused by network configuration.
CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25…
There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised…
CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5)…
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with…
Patient monitors may restart due to network overload caused by network configuration.
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the…
When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could…
specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date…
Patient monitors may restart due to network overload caused by network configuration.
CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25…
Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that…
A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be…
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr…
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex…
The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that…
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.
