Boston Scientific AMS Control Pump Recall: Mislabeling Risk
Boston Scientific recalls AMS Artificial Urinary Sphincter Control Pumps with mislabeled packaging that may contain the wrong device. Affected units have specific UPN and serial numbers. Consumers should check their product details.
Lower-risk recall
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Contact the company
What happened, in plain English
Boston Scientific is recalling AMS Artificial Urinary Sphincter Control Pumps that have mislabeled packaging. This could mean the device contains a Control Pump instead of a Pressure Regulating Balloon, which might cause improper function. If you own this product, check the serial numbers and UPN to see if it's affected. Read more at govinfonow.com/recall/53625-boston-scientific-ams-control-pump-recall-mislabeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/53625-boston-scientific-ams-control-pump-recall-mislabeling-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0530-2025
Cite this page
“Boston Scientific AMS Control Pump Recall: Mislabeling Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53625-boston-scientific-ams-control-pump-recall-mislabeling-risk. Based on FDA recall #Z-0530-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0530-2025%22&limit=1).
Why it’s dangerous
The packaging may incorrectly label a Control Pump as a Pressure Regulating Balloon. This could lead to improper device function, but the recall does not mention serious injury risks. The hazard is related to incorrect labeling rather than immediate danger.
Who’s affected
People who own the AMS Artificial Urinary Sphincter Control Pump with the specific UPN number 72400098 and serial numbers listed in the recall. Those with medical devices for urinary control are most at risk.
How to tell if you have this one
Check the UPN number on the packaging (72400098) and the serial numbers listed: 1100366307, 1100366316, etc. The product was sold with specific expiration dates and lot numbers.
- Brand
Boston Scientific- Product
AMS Artificial Urinary Sphincter Control Pump- Category
Medical device
All 2 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
Ongoing- Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0530-2025 | AMS Artificial Urinary Sphincter Control Pump; UPN Number: 72400098. GTIN Number: 00878953000688. Lot Number: 32487464. Serial Numbers: 1100366307, 1100366316, 1100366309, 1100366317, 1100366310, 1100366319, 1100366311, 1100366320, 1100366312, 1100366321, 1100366313, 1100366323, 1100366314, 1100366324, 1100366315, 1100366325. Expiration Date: 09/24/2028 | 16 units |
| Z-0531-2025 | AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O; UPN Number: 72400024. GTIN Number: 00878953000626. Lot Numbers: 32500739, 32500821, 32500820. Serial Numbers: 1100366088, 1100366115, 1100366089, 1100366116, 1100366090, 1100366117, 1100366091, 1100366118, 1100366092, 1100366119, 1100366093, 1100366120, 1100366094, 1100366121, 1100366095, 1100366122, 1100366096, 1100366123, 1100366097, 1100366144, 1100366098, 1100366145, 1100366099, 1100366146, 1100366100, 1100366147, 1100366101, 1100366148, 1100366102, 1100366149, 1100366103, 1100366150, 1100366104, 1100366151, 1100366105, 1100366152, 1100366106, 1100366153, 1100366107, 1100366154, 1100366108, 1100366155, 1100366109, 1100366156, 1100366110, 1100366157, 1100366111, 1100366158, 1100366112, 1100366159, 1100366113, 1100366160, 1100366114. Expiration Date: 09/23/2028 | 52 units |
What to do — step by step
Check Product Details
Verify the UPN number (72400098) and serial numbers listed in the recall to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 15 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, New York, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this product?
Check the UPN number and serial numbers against the list provided in the recall. If your product matches, contact Boston Scientific for further instructions.
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Where this comes from
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-0530-2025 (October 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0530-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.