Complete FDA and NHTSA recall records dated in 2023, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen,…
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow…
Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on…
Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining…
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the…
Blister package had an unsealed edge compromising sterility.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow…
Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor…
There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow…
Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in…
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
