CLASS II Device recall · Reported 26 Oct 2016 · FDA Enforcement Report

Upper Torso Tray, Kit number PSS1554(B convenience custom recalled

Windstone Medical Packaging is recalling Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery, distributed nationwide in the US. The recall was initiated on 22 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers/ Expiration Dates: 58440 12/26/2014 57416 2/5/2015 56848 2/23/2015 59052 5/17/2015 58812 5/28/2015 63227 7/20/2015 61936 8/28/2015 59666 10/14/2015 65111 10/20/2015 64230 11/10/2015 65410 12/11/2015 66232 5/19/2016 67772 7/9/2016 57871 7/12/2016 68610 9/20/2016 78517 9/30/2016 70880 10/28/2016 71119 12/14/2016 74426 12/24/2016 73427 1/22/2017 72781 1/30/2017 73810 3/18/2017 78127 8/18/2017 79916 9/20/2017

Quantity recalled546 kits

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-0281-2017
FDA event ID: 71968
Recalling firm: Windstone Medical Packaging, Billings, MT
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2015
FDA classified: 20 Oct 2016
Reported: 26 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Masks, Gloves & PPE

Timeline

22 Apr 2015	Recall initiated by company
20 Oct 2016	Classified by FDA	+547 days
26 Oct 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

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes 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

Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room

Where it was distributed

Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Nationwide California Florida Georgia Illinois Kansas Louisiana Michigan New Jersey Nevada Texas Virginia Wyoming

Questions about this recall

Is Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery recalled?

Yes. Windstone Medical Packaging recalled Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-0281-2017.

Why was it recalled?

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

Which lots are affected?

Lot Numbers/ Expiration Dates: 58440 12/26/2014 57416 2/5/2015 56848 2/23/2015 59052 5/17/2015 58812 5/28/2015 63227 7/20/2015 61936 8/28/2015 59666 10/14/2015 65111 10/20/2015 64230 11/10/2015 65410 12/11/2015 66232 5/19/2016 67772 7/9/2016 57871 7/12/2016 68610 9/20/2016 78517 9/30/2016 70880 10/28/2016 71119 12/14/2016 74426 12/24/2016 73427 1/22/2017 72781 1/30/2017 73810 3/18/2017 78127 8/18/2017 79916 9/20/2017

Where was it sold?

Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

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 Windstone Medical Packaging

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5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Packaging Defects	Nationwide
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Other Masks, Gloves & PPE recalls

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29 Jul 2026Device	CLASS II	P28 Phanton Intramedullary Nail System recalled by Paragon 28	Paragon 28	Sterility	Nationwide
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8 Jul 2026Device	CLASS II	Adapter for Head Positioning recalled by Baxter Healthcare	Baxter Healthcare	Other	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray Incorporated	Device Malfunction	Nationwide
3 Jun 2026Device	CLASS II	Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled	O&m Halyard	Other	Nationwide