Boston Scientific AMS 7:100 mL Spherical Reservoir Mislabeled as Conceal Reservoir
Boston Scientific recalls AMS 700 penile prosthesis reservoirs mislabeled as 100 mL Conceal when they are 100 mL Spherical. This affects specific lot numbers and part numbers.
Lower-risk recall
An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
Contact the company
What happened, in plain English
Boston Scientific is recalling certain AMS 700 inflatable penile prosthesis reservoirs that were incorrectly labeled. This mislabeling could lead to improper use if someone assumes it's a different type of reservoir. Read more at govinfonow.com/recall/62901-boston-scientific-ams-7-100-ml-spherical-reservoir-mislabeled-as.
Source Summary by GovInfoNow · govinfonow.com/recall/62901-boston-scientific-ams-7-100-ml-spherical-reservoir-mislabeled-as · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1433-2021
Cite this page
“Boston Scientific AMS 7:100 mL Spherical Reservoir Mislabeled as Conceal Reservoir.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62901-boston-scientific-ams-7-100-ml-spherical-reservoir-mislabeled-as. Based on FDA recall #Z-1433-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1433-2021%22&limit=1).
Why it’s dangerous
The reservoirs were mislabeled as 100 mL Conceal when they are actually 100 mL Spherical. This could cause confusion during use if someone assumes the reservoir is a different type, potentially leading to improper use.
Who’s affected
Men who own or use the AMS 700 penile prosthesis with specific part numbers (720185-01, 72404156) and lot numbers (26147100, 26154112) are affected. Those most at risk are users who might not notice the label difference.
How to tell if you have this one
Check for part numbers 720185-01 or 72404156 and lot numbers 26147100 or 26154112 on the reservoir packaging. The product is a closed fluid-filled system for penile prostheses.
- Brand
Boston Scientific- Category
Medical device
What to do — step by step
Check Reservoir Label
Look for part numbers 720185-01 or 72404156 and lot numbers 26147100 or 26154112 on the reservoir packaging.
Where it went and when
Where it was distributed
Distributed in 14 states, and outside the U.S.
FDA distribution: “Worldwide distribution. US distribution to AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, and UT. Belgium, France, Portugal” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Arkansas, Colorado, Florida, Georgia, Iowa, Michigan, Missouri, Nebraska, Oregon, Pennsylvania, Tennessee, Texas, Utah.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the AMS 700 penile prosthesis?
The AMS 700 is a closed fluid-filled system containing saline, made of silicone, with a pump, two cylinders, a fluid reservoir, and kink-resistant tubing for creating erections in men with chronic erectile dysfunction.
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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-1433-2021 (March 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1433-2021 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.