CLASS II Device recall · Reported 8 Mar 2017 · FDA Enforcement Report

Lumbar Laminectomy Pack recalled by Windstone Medical Packaging

Windstone Medical Packaging is recalling Lumbar Laminectomy Pack, distributed in 26 states. The recall was initiated on 11 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number and expiration date 83672, 5/11/2018 84748, 6/3/2018 86722, 8/19/2018 88051, 1/7/2018 89026, 11/21/2018 89027, 12/12/2018 89882, 12/10/2018 94933, 1/29/2019
Quantity recalled123 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-1336-2017
FDA event ID
76280
Recalling firm
Windstone Medical Packaging, Billings, MT
Classification
Class II
Status
Terminated
Recall initiated
11 Jan 2017
FDA classified
28 Feb 2017
Reported
8 Mar 2017
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Sterility

Timeline

11 Jan 2017Recall initiated by company
28 Feb 2017Classified by FDA+48 days
8 Mar 2017Published 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

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits 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

Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part number AMS2501(A Lumbar Laminectomy Pack, part number AMS2501(B

Where it was distributed

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

ArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKansasLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNorth DakotaNebraskaNew JerseyNevada

Questions about this recall

Why was it recalled?

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Which lots are affected?

Lot number and expiration date 83672, 5/11/2018 84748, 6/3/2018 86722, 8/19/2018 88051, 1/7/2018 89026, 11/21/2018 89027, 12/12/2018 89882, 12/10/2018 94933, 1/29/2019

Where was it sold?

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

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

100 other products · FDA event 76280

This product is part of a recall event; the main page for the event is Nasal Pack recalled by Windstone Medical Packaging.

ReportedClassRecallCompanyReasonWhere
CLASS IINasal Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIUpper Torso Tray recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIGeneral Surgery Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIMinor/General/Ortho Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IISurgical Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIMajor Pack (1345) recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIOrtho Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIOrbitofacial Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIKnee Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IITransvaginal Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIMajor Kit recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IITotal Hip Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IILaparotomy Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IILaparoscopy Pack (1184) recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIVascular Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIHSG Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIBasic Setup Tray recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IINewport Coast Basic Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIArthroscopy Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIGeneral Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIC-Tray Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIBasic Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIMajor Laparotomy Pack - NS recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIPlastic Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IICustom Venous Kit recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IID & C Kit recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIEye Plastic Tray, part number PSS1931(A recalledWindstone Medical PackagingSterility26 states
CLASS IIRobotic Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IILap Band Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IICustom Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIBayview Breast Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIMinor Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIMajor Breast Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IILap Chole Pack (6037) recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IID&C/Cysto Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIHand Tray recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIFacial Tray recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIKnee Arthroscopy Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIFoot Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIHip Pack (1347) recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIMinor Procedure Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIBreast Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IILaminectomy Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIMorris Hysto Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIBasic Face Kit recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIDr. Newman Surgical Procedure Pack recalledWindstone Medical PackagingSterility26 states
CLASS IIAnterior Cervical Fusion Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIBasic Kit recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIMinor Tray recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIDr. Casey Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IILap Minor Pack (1346) recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IISet-Up Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IILaparoscopic Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIOpen Procedure Pack II recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIBasic Tray recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIHead/Neck Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIShoulder Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIKnee Scope Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIExtremity Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIReduction Mammoplasty Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIAugmentation Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIGeneral Plastics Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IILiposuction Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IITotal Knee Pack (15710) recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIGYN Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IILap Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIOcular Plastic Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIOpgrande Hand Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIHysteroscopy Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIExtremity Pack (1344) recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIChest Breast Drape recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IISpine Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIShoulder Arthroscopy Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIBasic Setup Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIBasin Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIUpper Extremity Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIHystero Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIPacemaker Kit recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIEye Tray recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IICatheter Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IILipo Pack, part AMS4420(A recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIOrtho Minor Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IILap/Pelviscopy Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIGeneral Laparoscopy Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IID & C Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIGeneral Plastic Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIBleph Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIBasic Extended Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIVein Tray recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IICustom Pack - with Introducer Kit recalledWindstone Medical PackagingSterility26 states
CLASS IIENT Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIPlastic Surgery Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIHead Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIArthroscopy Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIPodiatry Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IITotal Joint Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IICustom Breast Augmentation Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIGYN Lap Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIHand Pack recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states
CLASS IIPeri GYN recalled by Windstone Medical PackagingWindstone Medical PackagingSterility26 states

More recalls from Windstone Medical Packaging

All 337
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIAMS Convenience Kit: Dsaek Pack - RX recalledWindstone Medical PackagingDevice MalfunctionNationwide
DeviceCLASS IIAms Aligned Medical Solutions medical convenience kits recalledWindstone Medical PackagingSterilityNationwide
DeviceCLASS IIAms Aligned Medical Solutions medical convenience kits recalledWindstone Medical PackagingPackaging DefectsNationwide
DeviceCLASS IIAms Aligned Medical Solutions medical convenience kits recalledWindstone Medical PackagingPackaging DefectsNationwide
DeviceCLASS IIAms Aligned Medical Solutions medical convenience kits recalledWindstone Medical PackagingPackaging DefectsNationwide

Other Other Medical Devices recalls

All 13,778
ReportedClassRecallCompanyReasonWhere
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DeviceCLASS IKit: Epidural/Pain TQC 20/Cs recalled by Medical Action IndustriesMedical Action Industries Inc. 306Sterility6 states
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DeviceCLASS IKit: Single Shot Epidural 20/Cs recalled by Medical Action IndustriesMedical Action Industries Inc. 306Sterility6 states
DeviceCLASS IIAMS Convenience Kit: Dsaek Pack - RX recalledWindstone Medical PackagingDevice MalfunctionNationwide