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

Open Procedure Pack II, Kit number RMS1740(A convenience recalled

Windstone Medical Packaging is recalling Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general, 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: 59942 4/3/2015 59692 4/19/2015 59858 11/25/2015 65398 11/30/2015 66543 7/4/2016 67496 9/14/2016 70943 1/31/2017 70944 8/11/2017 79014 9/17/2017 79771 1/10/2018

Quantity recalled145 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-0252-2017
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: Other Medical Devices

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

Open Procedure Pack II, Kit number RMS1740(A 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

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: 59942 4/3/2015 59692 4/19/2015 59858 11/25/2015 65398 11/30/2015 66543 7/4/2016 67496 9/14/2016 70943 1/31/2017 70944 8/11/2017 79014 9/17/2017 79771 1/10/2018

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 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 71968

This product is part of a recall event; the main page for the event is D&C/Cysto Pack, Kit number PSS3257, PSS3257(A recalled.

Reported	Class	Recall	Company	Reason	Where
26 Oct 2016	CLASS II	D&C/Cysto Pack, Kit number PSS3257, PSS3257(A recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Shoulder Arthroscopy Pack, Kit number 002648 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Cardiac Cath Pack, kit number AMS2707 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	C-Birth Pack, Kit recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Minor Arthroscopy Pack, Kit number recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Spine Pack, Kit number AMS3753 recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Foot Pack, Kit number AMS3637 convenience custom kits used recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Minor Lap Pack, Kit number AMS2624 convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Set Up Pack, Kit number PSS3574(A convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Major Kit, Kit number PHC1307(A convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Taymour GYN Pack, Kit number PSS2642 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Laparotomy Kit, Kit number PSS1036(A recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Transvaginal Pack, Kit number CMP1767 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Student Pack-NS, Kit number PSS2788 convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Abdominoplasty Tray, there are two Kit part numbers recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Augmentation Mammoplasty Tray, Kit recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Ortho Pack, Kit number PSS3466 recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Mammoplasty Pack, Kit number AMS2535 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Major Breast Pack, Kit number AMS3409 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Robotic Pack, Kit number AMS4389 convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Face Pack, Kit number AMS3641 convenience custom kits used recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Mok Eye Pack, Kit number PSS2640 convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Ocular Plastic Pack, Kit number AMS3868 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Universal Pack, Kit number AMS2036 convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Extremity Pack, Kit number AMS2726, AMS2937, AMS3240 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Lap Gallbladder Pack, Kit number AMS3707 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Hall SAP, Kit number SRK1031(A convenience custom kits used recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Laparotomy Tray, Kit number PSS1538 convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Dr. Casey Pack, kit number AMS4313 convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Virginia Custom Pack, Kit number RMS1744 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Body Contour Pack, Kit recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Basic Tray, Kit part numbers AMS1199(A recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Liposuction Pack, Kit number AMS3323 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Major Lithotomy Pack, kit number recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Percutaneous Entry Kit, Kit number TVS4022(C recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Cath Pack, kit number AMS4283 convenience custom kits used recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Custom Pack - with Introducer Kit recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Newport Coast Basic Pack, Kit number 007484-1 convenience recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Morris Lap Pack, Kit number PSS3199 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Basin Pack, kit number AMS2497 convenience custom kits used recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Breast Pack, Kit recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Custom Tray, Kit numbers: PSS1836 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Bayview Breast Pack, Kit part numbers recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Knee Pack, Kit number AMS4211 convenience custom kits used recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Basic Kit, Part numbers BP1110(C and CMP1109(A recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Lap/Hyst Pack, Kit number AMS2539 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Extremity Pack-N Brunswick, kit number PSS1866(A recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Custom Arterial Pack, kit number RMS1712(F convenience recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	General Pack II, Kit number CMP1812(B convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Bleph Pack, Kit recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Pacemaker Kit, Kit number AMS4281 convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	ENT Tray, Kit number AMS1195(A convenience custom kits used recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Laparoscopy Pack, Kit number AMS2537 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Major Ortho Pack, kit number recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Dr. Harrimans Kit, Kit number PSS3600 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Minor Tray AMS2685 convenience custom kits used recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Head Pack recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Hernia Pack, Kit number AMS1519 convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Major General Pack, Kit number recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Dr. Fritsch Pack, Kit number AMS2696 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	GYN Pack, Kit number PSS2643 convenience custom kits used recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Lipo Pack, Kit number AMS4420 convenience custom kits used recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Glbsc Minor Pack, Kit number PSS2644 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Lumbar Laminectomy Pack, Kit number AMS2501 convenience recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Extremity Tray, Kit number AMS1200(B recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Set-Up Pack, Kit number PSS1305(B recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Major Pack, Kit Number PSS3516 recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Eye, Kit number PSS1931(A convenience custom kits used recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Podiatry Kit PSS1040(A, PSS1040(B recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Minor Ortho Pack, Kit number recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Abdominoplasty Pack, Kit number AMS3326 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Dr Mullins Kit, kit number PSS1861(A convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Eye Tray, Kit number PSS1834 recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Total Joint Pack, Kit number recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Brow Pack, Kit recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	C-Section Pack, Kit number 002643 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Port Access Kit, Kit number PSS1505(C convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Ortho Minor Pack, Kit number AMS3710 convenience custom recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	OB/GYN Pack, Kit number AMS2038 convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Lithotomy Pack, Kit number AMS2333 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Peri Kit, Kit number PSS1037 convenience custom kits used recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Laparotomy Pack, Kit number 006047-2, 006268 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539 recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	GYN Lap Pack, Kit number PSS2194(B convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	D&C/GYN/Hysteroscopy Pack, Kit number PSS3341 convenience recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	C-Tray Pack, Kit number PSS2707and PSS2707(A convenience recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Minor Lithotomy Pack, Kit number 002650-7 convenience recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Total Hip Pack, Kit number PSS2956 convenience custom kits recalled	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Basic Setup Pack, kit recalled by Windstone Medical Packaging	Windstone Medical Packaging	Sterility	Nationwide
26 Oct 2016	CLASS II	Dr. Newman Surgical Procedure Pack recalled	Windstone Medical Packaging	Sterility	Nationwide

More recalls from Windstone Medical Packaging

All 337

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Sterility	Nationwide
5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Packaging Defects	Nationwide

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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