CooperSurgical 2 MHz Waterproof OB Probe Recalled for Incorrect Labeling
CooperSurgical recalls 2 MHz Waterproof OB probes due to being incorrectly labeled as 3 MHz. This may cause inaccurate fetal heart rate readings during obstetrical exams.
Lower-risk recall
The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe
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What happened, in plain English
CooperSurgical is recalling its 2 MHz Waterproof OB probes because they were incorrectly labeled as 3 MHz probes. This could lead to inaccurate fetal heart rate readings during obstetrical exams, potentially affecting pregnancy assessments. Read more at govinfonow.com/recall/72900-coopersurgical-2-mhz-waterproof-ob-probe-recalled-for-incorrect-labeling.
Source Summary by GovInfoNow · govinfonow.com/recall/72900-coopersurgical-2-mhz-waterproof-ob-probe-recalled-for-incorrect-labeling · Updated September 17, 2026 · FDA enforcement record: FDA #Z-1131-2018
Cite this page
“CooperSurgical 2 MHz Waterproof OB Probe Recalled for Incorrect Labeling.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72900-coopersurgical-2-mhz-waterproof-ob-probe-recalled-for-incorrect-labeling. Based on FDA recall #Z-1131-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1131-2018%22&limit=1).
Why it’s dangerous
The probe was labeled incorrectly as a 3 MHz device when it is actually a 2 MHz device. This mismatch could cause inaccurate fetal heart rate readings during exams, potentially leading to incorrect pregnancy assessments. However, the risk is low as the probe is designed for specific obstetrical use cases.
Who’s affected
Pregnant women and healthcare providers using the probe for obstetrical exams. Women with larger body sizes may be at slightly higher risk due to the probe's intended use.
How to tell if you have this one
Check for the product name 'CooperSurgical 2 MHz Waterproof OB Probe' on the label. The recall covers probes sold with incorrect labeling as 3 MHz devices.
- Brand
CooperSurgical- Category
Medical device
What to do — step by step
Check Label
Verify the probe's label to confirm it is labeled as a 2 MHz device, not 3 MHz.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Nationwide and the countries of ( Canada and England)” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this a safety hazard?
This is a low-risk issue as it affects accuracy of readings rather than causing physical harm. The probe is designed for specific obstetrical use.
Contact CooperSurgical
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1131-2018 — CooperSurgical 2 MHz Waterproof OB Probe Recalled for Incorrect Labeling Hello, I own a CooperSurgical 2 MHz Waterproof OB Probe Recalled for Incorrect Labeling that is covered by recall Z-1131-2018 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1131-2018 (October 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1131-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.