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Civco Medical Instruments Co. Inc.
Civco Medical Instruments Co. Inc.: 36 FDA recall reports
Every medical device recall the FDA has published for Civco Medical Instruments Co. Inc.. The fault, and how the agency graded it.
36Reports
0Class I
9Ongoing
2026-04-08Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
Z-1734-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Product
- eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
- Where it went
- US States: OH, PA, WA. China.
- How much
- 20 units
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Z-1738-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Product
- eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
- Where it went
- US States: OH, PA, WA. China.
- How much
- 21 units
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Z-1733-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Product
- eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
- Where it went
- US States: OH, PA, WA. China.
- How much
- 18 units
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
Z-1736-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Product
- eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
- Where it went
- US States: OH, PA, WA. China.
- How much
- 5 units
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
Z-1732-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Product
- eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
- Where it went
- US States: OH, PA, WA. China.
- How much
- 6 units
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
Z-1735-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Product
- eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
- Where it went
- US States: OH, PA, WA. China.
- How much
- 5 units
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
Z-1737-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Product
- eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
- Where it went
- US States: OH, PA, WA. China.
- How much
- 10 units
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
Z-1731-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Product
- eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
- Where it went
- US States: OH, PA, WA. China.
- How much
- 2 units
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use
Z-1892-2025 · Class II · reported 2025-06-11 · Ongoing
- Why it was recalled
- During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.
- Product
- BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
- Where it went
- OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark
- How much
- 506 boxes
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
Z-0396-2022 · Class II · reported 2021-12-29 · Terminated
- Why it was recalled
- There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- Product
- VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
- Where it went
- Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.
- How much
- 9 boxes (5 units/box)
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
Z-0395-2022 · Class II · reported 2021-12-29 · Terminated
- Why it was recalled
- There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- Product
- VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
- Where it went
- Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.
- How much
- 52 boxes (5 units/box)
VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
Z-0398-2022 · Class II · reported 2021-12-29 · Terminated
- Why it was recalled
- There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- Product
- VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
- Where it went
- Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.
- How much
- 599 boxes (5 units/box)
VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
Z-0397-2022 · Class II · reported 2021-12-29 · Terminated
- Why it was recalled
- There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- Product
- VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
- Where it went
- Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.
- How much
- 18 boxes (5 units/box)
SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSi
Z-0567-2019 · Class II · reported 2018-12-19 · Terminated
- Product
- SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 115 boxes
CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
Z-0576-2019 · Class II · reported 2018-12-19 · Terminated
- Product
- CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 135 boxes
CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 serie
Z-0565-2019 · Class II · reported 2018-12-19 · Terminated
- Product
- CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 73 boxes
SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with
Z-0566-2019 · Class II · reported 2018-12-19 · Terminated
- Product
- SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 297 boxes
CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranduc
Z-0574-2019 · Class II · reported 2018-12-19 · Terminated
- Product
- CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 49 boxes
CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5
Z-0573-2019 · Class II · reported 2018-12-19 · Terminated
- Product
- CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 20 boxes
CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile
Z-0569-2019 · Class II · reported 2018-12-19 · Terminated
- Product
- CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 234 boxes
SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-
Z-0563-2019 · Class II · reported 2018-12-19 · Terminated
- Why it was recalled
- The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
- Product
- SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 1,375 boxes
CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2
Z-0571-2019 · Class II · reported 2018-12-19 · Terminated
- Product
- CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 468 boxes
CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5c
Z-0572-2019 · Class II · reported 2018-12-19 · Terminated
- Product
- CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 613 boxes
CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transdu
Z-0564-2019 · Class II · reported 2018-12-19 · Terminated
- Why it was recalled
- The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
- Product
- CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 948 boxes
CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angl
Z-0562-2019 · Class II · reported 2018-12-19 · Terminated
- Why it was recalled
- The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
- Product
- CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 738 boxes
CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with steril
Z-0568-2019 · Class II · reported 2018-12-19 · Terminated
- Product
- CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 257 boxes
CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile
Z-0570-2019 · Class II · reported 2018-12-19 · Terminated
- Product
- CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 22 GAUGE, Rx.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 66 boxes
CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc.
Z-0575-2019 · Class II · reported 2018-12-19 · Terminated
- Product
- CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
- Where it went
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- How much
- 3 boxes
CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
Z-2947-2018 · Class II · reported 2018-09-05 · Terminated
- Why it was recalled
- The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
- Product
- CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
- Where it went
- United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
- How much
- 3 units
CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
Z-2946-2018 · Class II · reported 2018-09-05 · Terminated
- Why it was recalled
- The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
- Product
- CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
- Where it went
- United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
- How much
- 107 units
Showing the 30 most recent of 36. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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