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.
1,218 detailed records are currently available in this category.
Certain lots of product have the potential for a sterile barrier breach.
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain…
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased…
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Potential for mislabeled syringe produced by the i.v.STATION device.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain…
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to…
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose…
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain…
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may…
Due to nonconforming products being inadvertently distributed.
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may…
Product has the potential for false positive results
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is…
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may…
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is…
Medline has identified the presence of particulate within the fluid path of the Manifolds.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain…
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may…
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.
