Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Recalled by Merz North America, Inc. Due to The expiration date encoded in the UDI barcode...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Merz North America, Inc. directly.
Affected Products
PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
Quantity: 9,439 units
Why Was This Recalled?
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Merz North America, Inc.
Merz North America, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report