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.
26,155 detailed records are currently available in this category.
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105…
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105…
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2…
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105…
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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.
