ReQuest Measles IgG Rubeola IgG Enzyme Linked Immunoabsorbant Assay recall — FDA Z-0534-2026
Due to distributing the measles IgG IVD without a premarket approved/cleared.
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.
21,444 detailed records are currently available in this category.
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their…
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to incorrect product label (Incorrect product name identified on outer packaging).
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as…
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their…
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their…
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their…
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their…
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their…
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their…
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as…
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their…
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.