Lower riskMedical device recall · FDA · Published July 23, 2021
Aspen Norton Arm Kit Recall: Risk of Surgical Infection from Poor Sterilization
Aspen Surgical Products recalls Norton Arm Kits (product code 711400) manufactured between July 2019 and July 2021 due to potential sterilization failure increasing surgical infection risk.
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
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Contact the company
📍Recalling firmAspen Surgical Products, Inc.6945 Southbelt Dr SE · Caledonia, MI 49316-7664
✎ GovInfoNow plain-language explainer
Aspen Surgical Products is recalling Norton Arm Kits made between July 2019 and July 2021 because they may not have been properly sterilized, which could lead to surgical site infections during procedures. This affects medical professionals using these kits in operating rooms. Read more at govinfonow.com/recall/62161-aspen-norton-arm-kit-recall-risk-of-surgical-infection-from.
“Aspen Norton Arm Kit Recall: Risk of Surgical Infection from Poor Sterilization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62161-aspen-norton-arm-kit-recall-risk-of-surgical-infection-from. Based on FDA recall #Z-2390-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2390-2021%22&limit=1).
The FDA announced on July 23, 2021, that Aspen Surgical Products, Inc. voluntarily recalled Norton Arm Kits due to potential sterilization failures. The affected products may compromise sterile fields and increase the risk of surgical site infections.
How to tell if you have it
Brand: Aspen Surgical Products
Product: Norton Arm Kit (Product Code 711400; previous code 031001)
Sample Kit S711400
Lots manufactured between July 9, 2019 to July 9, 2021
The hazard
The FDA said the kits were manufactured with materials exceeding bioburden limits for the validated sterilization process. This means the firm cannot assure full sterilization, potentially compromising sterile fields and increasing surgical site infection risk.
Context
GovInfoNow's records show other recent recalls of similar products include Arrow Medical Kits Recall: Risk of Serious Injury from Contaminated Sterile Products (2026-04-21), Arrow Medical Kits Recall: Risk of Serious Injury from Compromised Sterility (2026-04-21), and Arrow Medical Kits Recall: Risk of Serious Injury from Contaminated Solutions (2026-04-21).
How to tell if you have this one
Check for product code 711400 (previous code 031001) on the kit. These kits were made between July 9, 2019 and July 9, 2021. The sample kit is labeled S711400.
Brand
Aspen Surgical Products
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US nationwide distribution. No foreign distribution.
Recall number
Product, codes & lots
Quantity
Z-2388-2021
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300; All lots manufactured between July 9, 2019 to July 9, 2021
1429
Z-2389-2021
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100; All lots manufactured between July 9, 2019 to July 9, 2021
4270
Z-2390-2021
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400; All lots manufactured between July 9, 2019 to July 9, 2021
124
Based on the official FDA remedy
What to do — step by step
Check Product Code
Look for product code 711400 (previous code 031001) on the kit label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US nationwide distribution. No foreign distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2390-2021 (July 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2390-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.