CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report

Shaver Handpiece Sterilization Tray recalled by Stryker Endoscopy

Stryker Endoscopy is recalling Shaver Handpiece Sterilization Tray. The recall was initiated on 19 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number 272-700-000: Lot number: 20476.1 23541 23837 26403 26404 26405 26676 27009 27518 28341 30248 34355 35932 36756 39705 05J034834 06con05774 06CON06360 06CON06846 06con06869 06con06960 06con08587 25067-1-12 26882-1-1 26882-1-11 26882-1-12 26882-1-13 26882-1-14 35200-1-1 36610-1-1 38820-1-1 39078-1-1 40504-2-1 40675-1-1 41231-1-1 41827-1-1 42085-1-1 42375-1-1 42527-1-1 42789-1-1 43103-1-1 43589-1-1 43716-1-1 43716-1-3 43716-1-4 44568-1-10 44568-1-11 44568-1-2 44568-1-3 44568-1-4 44568-1-6 44568-1-7 44568-1-8 44568-1-9 46227-1-1 47731-1-1 48595-1-1 48596-1-1 48597-1-1 48598-1-1 48599-1-1 48600-1-1 50101-1-1 50628-1-1 50828-1-1 51237-1-1 52439-1-1 55035-1-1 55422-1-1 55462-1-1 56456-1-1 R471611 SS15329.

Quantity recalled1992 trays

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1872-2014
FDA event ID: 68405
Recalling firm: Stryker Endoscopy, San Jose, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 May 2014
FDA classified: 25 Jun 2014
Reported: 2 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

19 May 2014	Recall initiated by company
25 Jun 2014	Classified by FDA	+37 days
2 Jul 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.

Where it was distributed

Worldwide Distribution.

Questions about this recall

Is Shaver Handpiece Sterilization Tray recalled?

Yes. Stryker Endoscopy recalled Shaver Handpiece Sterilization Tray on 19 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1872-2014.

Why was it recalled?

STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.

Which lots are affected?

Part Number 272-700-000: Lot number: 20476.1 23541 23837 26403 26404 26405 26676 27009 27518 28341 30248 34355 35932 36756 39705 05J034834 06con05774 06CON06360 06CON06846 06con06869 06con06960 06con08587 25067-1-12 26882-1-1 26882-1-11 26882-1-12 26882-1-13 26882-1-14 35200-1-1 36610-1-1 38820-1-1 39078-1-1 40504-2-1 40675-1-1 41231-1-1 41827-1-1 42085-1-1 42375-1-1 42527-1-1 42789-1-1 43103-1-1 43589-1-1 43716-1-1 43716-1-3 43716-1-4 44568-1-10 44568-1-11 44568-1-2 44568-1-3 44568-1-4 44568-1-6 44568-1-7 44568-1-8 44568-1-9 46227-1-1 47731-1-1 48595-1-1 48596-1-1 48597-1-1 48598-1-1 48599-1-1 48600-1-1 50101-1-1 50628-1-1 50828-1-1 51237-1-1 52439-1-1 55035-1-1 55422-1-1 55462-1-1 56456-1-1 R471611 SS15329.

Where was it sold?

Worldwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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