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.
23,781 detailed records are currently available in this category.
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may…
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may…
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may…
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may…
M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling…
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may…
***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for…
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine…
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated…
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may…
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated…
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated…
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated…
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may…
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may…
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may…
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
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.
