CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report

Ultra(R) Sterrad container recalled by Symmetry Surgical

Symmetry Surgical is recalling Ultra(R) Sterrad container. The recall was initiated on 29 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll

Quantity recalled149 units

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-1011-2017
FDA event ID: 75850
Recalling firm: Symmetry Surgical, Antioch, TN
Classification: Class II
Status: Terminated
Recall initiated: 29 Nov 2016
FDA classified: 11 Jan 2017
Reported: 18 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

29 Nov 2016	Recall initiated by company
11 Jan 2017	Classified by FDA	+43 days
18 Jan 2017	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

Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.

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

symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C18138-SP, C22854-SP, C22855-SP, C22856-SP, C22858-SP, C24134-SP, C24135-SP, C24136-SP, C24138-SP Product Usage: sterilization container

Where it was distributed

Worldwide Distribution

Questions about this recall

Why was it recalled?

Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.

Which lots are affected?

All

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

Other products in this recall event

2 other products · FDA event 75850

This product is part of a recall event; the main page for the event is Ultra(R) Steam container recalled by Symmetry Surgical.

Reported	Class	Recall	Company	Reason	Where
18 Jan 2017	CLASS II	Ultra(R) Steam container recalled by Symmetry Surgical	Symmetry Surgical	Sterility	TN
18 Jan 2017	CLASS II	Ultra(R) Gravity container recalled by Symmetry Surgical	Symmetry Surgical	Sterility	TN

More recalls from Symmetry Surgical

All 4

Reported	Class	Recall	Company	Reason	Where
18 Jan 2017Device	CLASS II	Ultra(R) Gravity container recalled by Symmetry Surgical	Symmetry Surgical	Sterility	TN
18 Jan 2017Device	CLASS II	Ultra(R) Steam container recalled by Symmetry Surgical	Symmetry Surgical	Sterility	TN
5 Aug 2015Device	CLASS II	Disposable Towel Clamp recalled by Symmetry Surgical	Symmetry Surgical	Sterility	18 states

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