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

Cotton Balls-Strung 1.25" recalled by American Surgical

American Surgical is recalling Cotton Balls-Strung 1.25", 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: 2015/09 CK 2015/10 BF

Quantity recalled25 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-1758-2016
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 Cotton Balls-Strung 1.25" Ref Number: 30-05 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

Why was it recalled?

Product packaging defective compromising sterility

Which lots are affected?

Lot numbers: 2015/09 CK 2015/10 BF

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 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

90 other products · FDA event 73734

This product is part of a recall event; the main page for the event is Cotton Balls-Strung 1/2" recalled by American Surgical.

Reported	Class	Recall	Company	Reason	Where
1 Jun 2016	CLASS II	Cotton Balls-Strung 1/2" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Policot 1/2" x 1/2" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ultracot (Glassine) recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ray-Cot 1/2" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Ultracot 70 mm x 10090 mm Ref Number recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot Blue 1/2" x 1/2" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot Blue 3/8" x 2" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Uniqcot 1/2" x 1/2" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ultracot (Glassine) recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ultracot (Glassine) recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Delicot non-xray recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot Blue 1/4" x 1.5" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot Blue 1" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Delicot non-xray recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Telfa 3/8" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Telfa 3/4" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Uniqcot 1/4" x 1/4" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ray-Cot 1/4" x 1/4" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ultracot (Glassine) recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ray-Cot 1.5" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Uniqcot 1/2" x 2" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ray-Cot 1/2" x 1/2" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot Blue 1/2" x 2" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Cotton Balls-Strung 1" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Uniqcot 1/2" x 1.5" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot Blue 1/2" x 1.5" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Cotton Balls-Strung 3/4" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ray-Cot 1/2" x 1" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Cylindrical Sponges-Strung 1/2" x 1.5" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot Blue 1/4" x 1/4" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot White x recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ultracot (Glassine) recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Policot 1/4" x 1/4" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ultracot (Glassine) recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Telfa 1" x 1" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Cotton Balls-Non-Strung 1" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Policot 1/2" x 2" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Cotton Balls-Non-Strung 3/4" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ray-Cot 1/2" x 2" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Cotton Balls-Strung 1/4" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Telfa 1/2" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Telfa 1/2" x 1.5" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ray-Cot 3" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ray-Cot 1/2" x 1.5" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Delicot non-xray recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ray-Cot 1/4" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ultracot (Glassine) recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Policot 1/2" x 1.5" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot Blue 3/8" x 3/4" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Telfa 1" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ultracot (Glassine) recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot Blue 1/8" x 1/8" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ray-Cot 1" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Telfa 1/2" x 1/2" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Cotton Balls-Strung 1/8" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ultracot (Glassine) recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Cotton Balls-Non-Strung 1/8" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Cotton Balls-Strung 3/8" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot Blue 3/8" x 3/8" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot Blue 1/2" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Americot Blue 1/2" x 1" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ray-Cot 1" x 1" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product recalled	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Ultracot (Glassine) recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Uniqcot 1/2" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Tonsil Sponges 1" Large recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016	CLASS II	Mass Eye & Ear Finger Cot Nasal 2's recalled by American Surgical	American Surgical	Sterility	Nationwide

More recalls from American Surgical

All 92

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024Device	CLASS II	Americot 20-01S (1/4" x 1/4") or: Neurological sponges recalled	American Surgical	Device Malfunction	8 states
1 Jun 2016Device	CLASS II	Mass Eye & Ear Finger Cot Nasal 2's recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016Device	CLASS II	Tonsil Sponges 1" Large recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016Device	CLASS II	Uniqcot 1/2" x 3" recalled by American Surgical	American Surgical	Sterility	Nationwide
1 Jun 2016Device	CLASS II	Ultracot (Glassine) recalled by American Surgical	American Surgical	Sterility	Nationwide

Other Surgical Instruments recalls

All 3,809

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9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide