Waldemar Link Prosthesis Head B Recall: Inconsistent Labeling
Waldemar Link recalls Prosthesis Head B (28mm, 7mm neck) due to inconsistent size labeling. Affected units have specific serial numbers and item numbers. Consumers should check their product details to determine if recalled.
Lower-risk recall
Inconsistent size terminology and color coding used on labeling
Contact the company
What happened, in plain English
Waldemar Link is recalling Prosthesis Head B models with inconsistent size terminology and color coding on labels. This could lead to incorrect fitting and potential complications for users. Read more at govinfonow.com/recall/51786-waldemar-link-prosthesis-head-b-recall-inconsistent-labeling.
Source Summary by GovInfoNow · govinfonow.com/recall/51786-waldemar-link-prosthesis-head-b-recall-inconsistent-labeling · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2288-2025
Cite this page
“Waldemar Link Prosthesis Head B Recall: Inconsistent Labeling.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51786-waldemar-link-prosthesis-head-b-recall-inconsistent-labeling. Based on FDA recall #Z-2288-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2288-2025%22&limit=1).
Why it’s dangerous
The inconsistent size terminology and color coding on the product labels could result in incorrect fitting of the prosthetic limb. This might cause discomfort, improper function, or complications if the prosthetic does not match the user's needs.
Who’s affected
Users of prosthetic limbs who own the recalled Prosthesis Head B models (28 mm, 7 mm neck length) with specific serial numbers and item numbers are affected. Individuals with custom prosthetics may be at higher risk due to potential misfit.
How to tell if you have this one
Check for the item number 198-828/04 on the product label. Affected units have specific serial numbers listed in the recall notice, including ranges like 211117/0069 to 221011/0093.
- Brand
Waldemar Link- 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, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2288-2025 | Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.; Item Number: 198-828/04. UDI-DI: 04026575193783. Serial Numbers: 211117/0069, 211117/0070, 211117/0071, 211117/0073, 211117/0078, 220204/0613, 220204/0614, 220204/0615, 220204/0616, 220204/0617, 220204/0618, 220204/0619, 220204/0620, 220204/0621, 220204/0622, 220204/0623, 220204/0624, 220204/0627, 220304/0074, 220304/0075, 220304/0076, 220304/0077, 220304/0078, 220304/0080, 220304/0081, 220304/0082, 220304/0083, 220517/0052, 220517/0069, 220517/0070, 220517/0071, 220517/0072, 220517/0073, 220517/0074, 220517/0076, 220517/0078, 220517/0079, 220517/0080, 220517/0081, 220517/0085, 220517/0088, 220517/0089, 220517/0090, 221011/0093, 240415/3890, 240415/3896. | 46 units |
| Z-2289-2025 | Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.; Item Number: 175-928/15. UDI-DI: 04026575150700. Serial Numbers: C126168, C424053 | 17 units |
What to do — step by step
Check Product Label
Look for the item number 198-828/04 and serial numbers listed in the recall notice to determine if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Indiana, Kansas, Louisiana, New Jersey.
Recall timeline
FDA published this recall 36 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.
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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-2288-2025 (July 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2288-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.