Recall Register

Food, drugs, devices › Firms

Windstone Medical Packaging, Inc.

FDA recalling firm · 20 enforcement events · 337 product records · 2015–2026 · MT

Windstone Medical Packaging, Inc. has 20 FDA enforcement events on this register (337 product records) between 2015 and 2026: 20 device; the busiest year was 2026 with 7.

20% of its events are Class I; the most common class is Class II (16). 13 events are listed as ongoing; the recalling firm's address is in MT.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
29 Jul 2026AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394BDeviceClass II1Ongoing
17 Jun 2026AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683ADeviceClass II8Ongoing
8 Jun 2026AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, Part Number AMS12636C; 5) Lumbar Lami Pack, Part Number AMS12731; 6) Septoplasty Pack, Part Number AMS13150; 7)…DeviceClass II4Ongoing
21 May 2026A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kitDeviceClass I4Ongoing
27 Apr 2026Aligned Medical AMS16835 Fluids Kit RXDeviceClass II1Ongoing
2 Apr 2026Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908FDeviceClass I1Ongoing
11 Mar 2026Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433DeviceClass II3Ongoing
16 Aug 2024Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.DeviceClass II5Ongoing
22 Dec 2023Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEODeviceClass I4Ongoing
24 Apr 2023Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EODeviceClass II3Ongoing
1 Nov 2022Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B…DeviceClass II1Ongoing
21 Mar 2022Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573, Ultrasound Biopsy Pack -Rx/AMS6828,…DeviceClass II1Ongoing
19 Aug 2021Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and…DeviceClass I1Ongoing
8 Apr 2021Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22 2 Prep ChloraPrep One-Step 3 1 Dressing…DeviceClass II2Terminated
24 Oct 2017AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.DeviceClass II1Terminated
16 Mar 2017Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedureDeviceClass II18Terminated
11 Jan 2017Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.DeviceClass II124Terminated
21 Mar 2016Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" W/L.DeviceClass II3Terminated
2 Nov 2015AMS 4674 Custom Pack. For use in a general clinical procedure.DeviceClass II2Terminated
22 Apr 2015Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating roomDeviceClass II150Terminated

By type and class

Device20
Class II16
Class I4

Class I: 20% of this firm's events; 18% of all events on the register.

Events by year

15
16
17
18
19
20
21
22
23
24
25
26
Enforcement events for Windstone Medical Packaging, Inc. by year initiated.

Questions and answers

How many FDA recalls has Windstone Medical Packaging, Inc. had?

20 enforcement events (337 product records) on this register, 2015–2026: 20 device.

Are any Windstone Medical Packaging, Inc. recalls ongoing?

13 events are listed as ongoing in the current openFDA export.

What class are Windstone Medical Packaging, Inc. recalls?

16 Class II, 4 Class I. 20% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.