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.
28,992 detailed records are currently available in this category.
Potential for compromise of the package resulting in a breach of the sterile barrier
DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot…
Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not…
Potential for compromise of the package resulting in a breach of the sterile barrier
Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).
Potential for compromise of the package resulting in a breach of the sterile barrier
Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle. Potential for delay in…
Potential for compromise of the package resulting in a breach of the sterile barrier
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot…
Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. The possible misalignment is the result of an assembly error…
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Potential for compromise of the package resulting in a breach of the sterile barrier
May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.
Potential for compromise of the package resulting in a breach of the sterile barrier
DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot…
Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner with a 1L canister. It is possible that…
The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior…
Potential for compromise of the package resulting in a breach of the sterile barrier
Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
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.
