CLASS II Device recall · Reported 1 Jun 2016 · FDA Enforcement Report

American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product recalled

American Surgical is recalling American Surgical Delicot, distributed nationwide in the US. The recall was initiated on 31 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers: 2015/08 BZ 2015/10 AG 2015/09 AW 2015/10 CD 2015/11 AZ 2015/11 BT 2015/12 AY 2015/11 BH 2015/12 CO 2015/12 DD

Quantity recalled338 boxes

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-1790-2016
FDA event ID: 73734
Recalling firm: American Surgical, Salem, MA
Classification: Class II
Status: Terminated
Recall initiated: 31 Mar 2016
FDA classified: 26 May 2016
Reported: 1 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

31 Mar 2016	Recall initiated by company
26 May 2016	Classified by FDA	+56 days
1 Jun 2016	Published in enforcement report	+6 days

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

Reason for recall

Product packaging defective compromising sterility

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

American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Where it was distributed

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

Nationwide

Questions about this recall

Is American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product recalled?

Yes. American Surgical recalled American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product on 31 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1790-2016.

Why was it recalled?

Product packaging defective compromising sterility

Which lots are affected?

Lot numbers: 2015/08 BZ 2015/10 AG 2015/09 AW 2015/10 CD 2015/11 AZ 2015/11 BT 2015/12 AY 2015/11 BH 2015/12 CO 2015/12 DD

Where was it sold?

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.

More recalls from American Surgical

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1 Jun 2016Device	CLASS II	Mass Eye & Ear Finger Cot Nasal 2's recalled by American Surgical	American Surgical	Sterility	Nationwide
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1 Jun 2016Device	CLASS II	Uniqcot 1/2" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
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1 Jun 2016Device	CLASS II	American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product recalled	American Surgical	Sterility	Nationwide

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