CLASS II Device recall · Reported 20 Dec 2017 · FDA Enforcement Report

Blue Burn Sheet, Sterile, 60" x 96" recalled by Dukal

Dukal is recalling Blue Burn Sheet, Sterile, 60" x 96", distributed nationwide in the US. The recall was initiated on 1 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: JT13607, JT17507, JT35207, JT09008, JT11308, JT15408, JT18408, JT18708, JT23408, JT24508, JT26408, JT28408, JT31408, JT33508, JT00609, JT04809, JT15209, JT18209, JT19209, JT22409, JT22709, JT23209, JT25309, JT25809, JT27509, JT30109, JT31309, JT32909, JT17510, JT23610, JT24010, JT24810, JT30810, JT35910, JT00811, JT05011, JT07911, JT11511, JT15911, JT17011, JT18211, JT21511, JT26311, JT28411, JT30711, JT00812, JT07312, JT11812, JT13612, JT17712, JT21812, JT25612, JT33012, JT36112, JT36212, JT09113, JT17513, JT24713, JT29813, JT33513, JT01614, JT04614, JT06814

Quantity recalled12095 cases/12 Packs per case/1 sheet

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-0233-2018
FDA event ID: 77673
Recalling firm: Dukal, Ronkonkoma, NY
Classification: Class II
Status: Terminated
Recall initiated: 1 Jun 2017
FDA classified: 12 Dec 2017
Reported: 20 Dec 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

1 Jun 2017	Recall initiated by company
12 Dec 2017	Classified by FDA	+194 days
20 Dec 2017	Published in enforcement report	+8 days

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

Reason for recall

Intact carton revealed presence of shredded burn sheets

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

BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.

Where it was distributed

Worldwide distribution - US Nationwide in the states of: CA, CO, CT, FL, GA, IL, CO, NY, NV, IN, MD, MO, MD OH, TN, TX & WI; and country of Canada

Nationwide California Colorado Connecticut Florida Georgia Illinois Indiana Maryland Missouri Nevada New York Tennessee Texas Wisconsin

Questions about this recall

Is Blue Burn Sheet, Sterile, 60" x 96" recalled?

Yes. Dukal recalled Blue Burn Sheet, Sterile, 60" x 96" on 1 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0233-2018.

Why was it recalled?

Intact carton revealed presence of shredded burn sheets

Which lots are affected?

Lot Numbers: JT13607, JT17507, JT35207, JT09008, JT11308, JT15408, JT18408, JT18708, JT23408, JT24508, JT26408, JT28408, JT31408, JT33508, JT00609, JT04809, JT15209, JT18209, JT19209, JT22409, JT22709, JT23209, JT25309, JT25809, JT27509, JT30109, JT31309, JT32909, JT17510, JT23610, JT24010, JT24810, JT30810, JT35910, JT00811, JT05011, JT07911, JT11511, JT15911, JT17011, JT18211, JT21511, JT26311, JT28411, JT30711, JT00812, JT07312, JT11812, JT13612, JT17712, JT21812, JT25612, JT33012, JT36112, JT36212, JT09113, JT17513, JT24713, JT29813, JT33513, JT01614, JT04614, JT06814

Where was it sold?

Worldwide distribution - US Nationwide in the states of: CA, CO, CT, FL, GA, IL, CO, NY, NV, IN, MD, MO, MD OH, TN, TX & WI; and country of Canada

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 Dukal

All 3

Reported	Class	Recall	Company	Reason	Where
26 Sep 2012Drug	CLASS II	BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 133% w/v recalled	Dukal	Sterility	Nationwide
26 Sep 2012Drug	CLASS II	ZEE Antiseptic Wipes, First Aid Antiseptic recalled by Dukal	Dukal	Sterility	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide