Lower riskMedical device recall · FDA · Published June 25, 2021
Straumann KeyPrint Soft- Bottle Recall: European Label in US Market
Straumann recalls 32.5 oz KeyPrint Soft- resin bottles sold in the US with European labels. These resin bottles are used for dental appliances like mouthguards. The recall is due to incorrect labeling for the US market.
“Straumann KeyPrint Soft- Bottle Recall: European Label in US Market.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62304-straumann-keyprint-soft-bottle-recall-european-label-in-us-market. Based on FDA recall #Z-2336-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2336-2021%22&limit=1).
The FDA announced on June 25, 2021, that Straumann USA LLC recalled KeyPrint Soft- bottles due to a labeling error. The product label intended for the European community was distributed to the U.S. market.
How to tell if you have it
Brand: Straumann
Product: KeyPrint Soft-
Size: 32.5 oz (1kg)
Model #: 4220005
Lot Number: KJ2858
Expiration Date: 22 April 2023
UDI: +H66842200051/$$3230422KJ2858U
Distribution: US Nationwide distribution in the state of TX
The hazard
The product label intended for the European community was distributed to the USA market via their US distribution organization.
Context
GovInfoNow's records show Straumann USA LLC has 13 other recalls on record since May 27, 2021. Recent Straumann recalls include a GM Helix Implant recall regarding packaging vs. actual dimensions mismatch on August 12, 2026, and a Bone Level Tapered Implant recall for potential wrong length on July 16, 2026. Other recent recalls of similar products include the Boston Scientific FARASTAR Ablation Generator EU Recall (June 11, 2026), Henry Schein Structur 2 SC Resin Cartridge Refills with Incorrect Packaging (July 9, 2026), and Omnicell i.v.Station Label Stock Recall (March 25, 2026).
How to tell if you have this one
Check for the product label intended for the European community. The bottles have a model number 4220005 and lot number KJ2858 with an expiration date of April 22, 2023.
Brand
Straumann
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Label
Look for the European label on the bottle instead of a US label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2336-2021 (June 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2336-2021 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.