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.
27,577 detailed records are currently available in this category.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected…
One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by…
Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot…
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct…
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct…
The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected…
The infusion sets were manufactured with an incorrect spin collar.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of…
The infusion sets were manufactured with an incorrect spin collar.
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic…
Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200…
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and…
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic…
The implant size is incorrectly etched on the implant. The size listed on the box is correct.
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic…
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.
