Manufacturer

Civco Medical Instruments Inc

9 recalls in our database name Civco Medical Instruments Inc as the manufacturing or recalling firm.

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2015-04-15

Of the 9 recalls from Civco Medical Instruments Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

HighFDA (Devices)·Z-1400-2015·2015-04-15
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.
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.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2558-2014·2014-09-03
Civco Medical Instruments Recalls CollectEVAC Sterile Devices Due to Packaging Leak
Civco Medical Instruments is recalling 52 kits of CollectEVAC sterile devices because a pinhole leak in the packaging could compromise sterility.
Product
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate o
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0802-2014·2014-01-29
Civco Belly Board Recalled Due to Misaligned Scales
Civco Medical Instruments is recalling 138 belly boards because scales may be misaligned from the zero reference, potentially affecting measurement accuracy.
Product
Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0803-2014·2014-01-29
Civco Belly Board MRI Recalled Due to Misaligned Scales
Civco Medical Instruments is recalling specific lots of Belly Board MRI devices because scales may be misaligned, potentially affecting measurement accuracy.
Product
Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1956-2012·2012-07-18
Civco VirtuTRAX Electromagnetic Sensor Recall Due to Calibration Error
Civco Medical Instruments is recalling 24 VirtuTRAX Instrument Navigator kits because incorrect sensor calibration may cause variability in projected needle paths during ultrasound procedures.
Product
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 610-1080. The firm name on the
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1953-2012·2012-07-18
Civco General Purpose Sensor Recalled for Calibration Errors
Civco Medical Instruments is recalling 30 kits of General Purpose Sensors due to incorrect calibration that may cause variability in needle path projection.
Product
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part numb
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1954-2012·2012-07-18
CIVCO General Purpose Sensor Recalled for Calibration Errors
Civco Medical Instruments is recalling 100 CIVCO General Purpose Sensors because incorrect calibration may cause variability in the projected position of the needle path.
Product
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part nu
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1952-2012·2012-07-18
Civco VirtuTRAX Electromagnetic Sensor Recalled for Calibration Errors
Civco Medical Instruments is recalling 221 VirtuTRAX kits because the electromagnetic sensors were incorrectly calibrated, which may cause variability in projected needle paths.
Product
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the l
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1955-2012·2012-07-18
CIVCO General Purpose Sensor Recalled for Calibration Errors
Civco Medical Instruments Inc is recalling 9 CIVCO General Purpose Sensor kits due to incorrect calibration that may affect needle path projection accuracy.
Product
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose s
Category
Medical Device
Distribution
6 states