Civco Medical Instruments Inc CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide per tyvek pouch, 20 pouches per box. The label shows the product is Mfg by CIVCO, Kalona, IA. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide per tyvek pouch, 20 pouches per box. The label shows the product is Mfg by CIVCO, Kalona, IA.
Brand
Civco Medical Instruments Inc
Lot Codes / Batch Numbers
Lot Numbers:M102250 and M105440
Products Sold
Lot Numbers:M102250 and M105440
Civco Medical Instruments Inc is recalling CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U tra due to Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-05. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054).
Recommended Action
Per FDA guidance
On 1/16/08, the recalling firm contacted their customers and notified them of the problem. Pictures of the problems were provided for identification. The firm requested that all products be returned.
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