Official recall notice

FDA DeviceClass IINotable

FDA Recall: STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530

Recall date
2026-08-12
FDA class
Class II

Why it was recalled

Hazard

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Product description

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Affected products

GTIN 07613327061352, Batch Numbers 24260FG2, 24261FG2, 24297FG2, 24298FG2, 24299FG2, 24302FG2, 24340FG2, 24341FG2, 25008FG2, 25009FG2, 25010FG2, 25011FG2, 25024FG2, 25034FG2, 25035FG2, 25052FG2, 25063FG2, 25064FG2, 25084FG2, 25092FG2, 25093FG2, 25121FG2, 25134FG2, 25135FG2, 25153FG2, 25154FG2, 25167FG2, 25182FG2, 25183FG2, 25216FG2, 25217FG2, 25245FG2, 25274FG2.

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