RecallRadar

FDA Device recall Z-2865-2026

STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530

On 2026-08-12 the FDA classified a Class II recall of STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 by Stryker, citing there has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2865-2026
ClassificationClass II
Statusongoing
Initiated2026-06-08
Published2026-08-12
Last updated2026-09-13 11:58 UTC
CompanyStryker
DistributionUS

Product

STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530

Reason

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

Identifiers

code_info
GTIN 07613327061352, Batch Numbers 24260FG2, 24261FG2, 24297FG2, 24298FG2, 24299FG2, 24302FG2, 24340FG2, 24341FG2, 250…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2865-2026%22

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