Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform recall — FDA Z-0089-2019
Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
Complete FDA and NHTSA recall records dated in 2018, 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.
Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have…
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed.…
There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may…
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure.
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed.…
The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.
Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and…
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Undeclared wheat and soy lecithin
Incorrect ingredients listed: Does not include Amaranth flour nor baking soda, but does include baking powder and vanilla
Undeclared wheat and soy lecithin
Undeclared wheat, soy lecithin, and milk
Product may contain undeclared milk.
Undeclared wheat, soy lecithin, and milk
Lloyd s Ice Cream of Evansville, IN is voluntarily recalling pre-packed quarts of Reese s Oreo Ice Cream because the product label does not declare peanuts.
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.