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.
3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex…
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Contact lenses lack sterility assurance.
All patient serum samples yield a weakly positive test result.
Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which…
Contact lenses lack sterility assurance.
Contact lenses lack sterility assurance.
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Update XL device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of information as needed…
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the…
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Contact lenses lack sterility assurance.
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Contact lenses lack sterility assurance.
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot…
The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography…
Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now…
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.
