Civco Medical Recalls Sterile Ultrasound Transducer Covers Due to Leaks
Civco Medical Instruments is recalling 120 sterile ultrasound transducer covers because leaks were detected that may compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device where leaks may compromise sterility, posing a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Civco Medical Instruments Inc is recalling 120 pouches of CIVCO Surgi-Tip Transducer Cover Sterile (REF 610-833). The product is a polyethylene telescopically-folded cover with an attached NeoGuard tip, packaged in Tyvek pouches with gel and fasteners. The recalled lot is M591280 (pouch) and M612600 (box), with an expiration date of 2018.01.
The recall was initiated because leaks were detected in the recalled lot, which may compromise the sterility of the product. The product is intended for use in scanning and needle-guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound.
The affected product was distributed to the states of California, Illinois, Massachusetts, Michigan, Missouri, and Wisconsin. Users should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12.
- Manufacturer
- Civco Medical Instruments Inc
- Affected units
- 120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Tyvek pouch - lot M591280
- Box lot - M612600 Expiration date 2018.01
Distribution
Related recalls
Same manufacturer · Civco Medical Instruments Inc
See all →- ModerateCivco Medical Instruments Recalls CollectEVAC Sterile Devices Due to Packaging Leak
FDA (Devices) · 2014-09-03
- ModerateCivco Belly Board MRI Recalled Due to Misaligned Scales
FDA (Devices) · 2014-01-29
- ModerateCivco Belly Board Recalled Due to Misaligned Scales
FDA (Devices) · 2014-01-29
- ModerateCIVCO General Purpose Sensor Recalled for Calibration Errors
FDA (Devices) · 2012-07-18
- HighCivco VirtuTRAX Electromagnetic Sensor Recalled for Calibration Errors
FDA (Devices) · 2012-07-18
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12