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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Windstone Medical Packaging, Inc.: Surgical Kits and Local Extremity Packs Recalled for Sterility Concerns

Agency Publication Date: February 16, 2024
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Summary

Windstone Medical Packaging, Inc. is recalling approximately 2,211 surgical kits and medical packs because the sterility of the saline included in these kits cannot be guaranteed. The recall affects four specific product types: Local Lower Extremity Pack I, In House Ocular Pack (two versions), and Closure Kits, which were distributed in Florida, Illinois, and California. Consumers and healthcare providers should check their inventory for these specific Aligned Medical Solutions products to prevent the use of non-sterile components during medical procedures.

Risk

If the saline included in these surgical kits is not sterile, it may introduce bacteria or other contaminants directly into a patient's surgical site or wound. This can lead to serious healthcare-associated infections, complications during surgery, or other adverse health outcomes.

What You Should Do

  1. Identify if you have any affected Aligned Medical Solutions products by checking the following model and lot numbers: for Local Lower Extremity Pack I (AMS10833), check for 26 specific lots including 173719, 176590, 174338, 175529, 176217, and others ending in 199297.
  2. For In House Ocular Pack (AMS12947A), check for lot numbers 192436, 192774, or 196582; for the standard Ocular Pack (AMS12947), check for lots 192389 and 194805.
  3. For Closure Kits (AMS13043), verify if you have lot numbers 178114, 187325, 191102, 195504, 196502, or 197864.
  4. Immediately stop using any kits identified as part of this recall to avoid the risk of patient infection.
  5. Contact your healthcare provider or Windstone Medical Packaging, Inc. directly at their Billings, Montana facility for further instructions regarding the return or replacement of affected kits and potential refund information.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Healthcare provider or manufacturer contact

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Model / REF:
AMS10833
Z-1079-2024
Lot Numbers:
173719
176590
174338
175529
176217
178271
178489
180907
183355
183674
184398
185064
188137
189007
189640
189641
189642
191067
192551
196380
197727
198046
198373
181439
194252
199297
Product: Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Model / REF:
AMS12947A
Z-1080-2024
Lot Numbers:
192436
192774
196582
Product: Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Model / REF:
AMS12947
Z-1081-2024
Lot Numbers:
192389
194805
Product: Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Model / REF:
AMS13043
Z-1082-2024
Lot Numbers:
178114
187325
191102
195504
196502
197864

Product Images

“Local Lower Extremity Pack Label product code AMS10833”

“Local Lower Extremity Pack Label product code AMS10833”

“In house Ocular Pack label product code AMS12947”

“In house Ocular Pack label product code AMS12947”

“In house Ocular Pack label product code AMS12947A”

“In house Ocular Pack label product code AMS12947A”

“Closure Kit label product code AMS13043”

“Closure Kit label product code AMS13043”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93807
Status: Active
Manufacturer: Windstone Medical Packaging, Inc.
Manufactured In: United States
Units Affected: 4 products (1,528 units; 128 kits; 80 kits; 475 kits)
Distributed To: Florida, Illinois, California
Agency Last Updated: February 26, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.