ATS Medical, Inc. CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console.
Brand
ATS Medical, Inc.
Lot Codes / Batch Numbers
Lot: 50515, 50602, 50609
Products Sold
Lot: 50515, 50602, 50609
ATS Medical, Inc. is recalling CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Queb due to Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiratation date while the correct date is one (1) year.
Recommended Action
Per FDA guidance
Consignee''s were notified by ATS Medical Representatives via visits. Product was either relabeled with correct expiration date or retrieved by ATS Medical representatives.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026