CIVCO Latex-Free Needle Guide, Sterile transrectal needle… recallZ-1054-2008 · Civco Medical Instruments Inc · initiated Jan 16, 2008
Terminated All recalls posted in March 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Civco Medical Instruments Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Packaging
What the company is doing
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.
Recall details
- Recall number
- Z-1054-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 16, 2008
- Posted by the FDA
- Mar 19, 2008
- Recalling firm
- Civco Medical Instruments Inc
- Quantity
- Lot M102250 - 5 boxes; Lot M105440 - 2 boxes
- Product code
- ITX
- FDA submissions
- K970514
- Distribution
- Nationwide Distribution- including states of TX and GA
Product description
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.
Code information (models, lots, serial numbers)
Lot Numbers:M102250 and M105440
Other devices under the same FDA submission
2 devices cleared under K970514 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Needle Guide 676-144, 10563771Civco Medical Instruments CO., Inc. · Transducer, ultrasonic, diagnostic1 recall0 reports
- Needle Guide 676-150Civco Medical Instruments CO., Inc. · Transducer, ultrasonic, diagnostic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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