DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124 recall — FDA Z-1562-2022
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
Complete FDA and NHTSA recall records dated in 2022, 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 webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
An incorrect sizing label was applied to the carton packaging.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.
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.