FDAJune 11, 2024device

Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 each/case), 6805-1 (175 each/case), 6810 (50 each/case), 6810-1 (350 each/case), 6830 (8 rolls/c...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foam pouches were misused due to misclassification of the GMDN.

What to do

FDA enforcement status: Ongoing

Brands named

medical action industries inc 306medicalmedical action

UPCs

208091600112532080916001126020809160012090208091600112842080916001131420809160011369208091600117412080916001187120809160012069208091600120762080916001208320809160012267

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 each/case), 6805-1 (175 each/case), 6810 (50 each/case), 6810-1 (350 each/case), 6830 (8 rolls/c... — Recall Details · AllClear