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Lower risk Medical device recall · FDA · Published June 3, 2020

CooperSurgical Os Finder Cervical Dilator Recall: Mislabeled Product

CooperSurgical recalls Os Finder Cervical Dilators (Part 1176) due to mislabeling. Products may show incorrect part numbers on packaging. Consumers should check labels and contact the company for details.

🇺🇸 FDA recall #Z-2498-2020Medical deviceCooperSurgical ›
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Contact the company

Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350
✎ GovInfoNow plain-language explainer

CooperSurgical is recalling Os Finder Cervical Dilators (Part Number 1176) because the packaging shows incorrect part numbers. This mislabeling could lead to confusion about which product is being used, but it does not pose a safety risk. Read more at govinfonow.com/recall/65059-coopersurgical-os-finder-cervical-dilator-recall-mislabeled-product.

Source Summary by GovInfoNow · govinfonow.com/recall/65059-coopersurgical-os-finder-cervical-dilator-recall-mislabeled-product · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2498-2020

Cite this page

“CooperSurgical Os Finder Cervical Dilator Recall: Mislabeled Product.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65059-coopersurgical-os-finder-cervical-dilator-recall-mislabeled-product. Based on FDA recall #Z-2498-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2498-2020%22&limit=1).

CooperSurgical, Inc. recalled COOPERSURGICAL Os Finder Cervical Dilators on June 3, 2020, after the FDA announced the device was mislabeled as a Pipet Current. The Food and Drug Administration issued the recall for 2,250 units distributed nationwide.

How to tell if you have it

  • Brand: CooperSurgical
  • Product: COOPERSURGICAL Os Finder Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
  • Lot: 284288
  • Expiration date: 02/24/2023

The hazard

The printing on the top web or Tyvek lid of the individual product blister tray incorrectly indicated that it contained a Pipet Current with Part Number MX140. The display box also indicated the correct Os Finder Cervical Dilators, Part Number 1176, creating a labeling discrepancy.

Context

GovInfoNow's records show CooperSurgical, Inc. has 37 other recalls on record since 2017-10-06. Recent brand recalls include the 2026-08-11 Neonatal CPAP Replacement Set for loose tubing and the 2025-06-11 HSG Procedure Tray for non-sterile iodine pouches mislabeled as sterile. Other recent recalls of similar products include the Diversatek Viper 3-Stage Balloon Dilator (2026-03-18), Medtronic Octopus 4 Tissue Stabilizer Model 29400 (2026-05-12), and Centinel Prodisc C SK U.S. Implant Extra Large 5mm (2026-03-20).

How to tell if you have this one

Check the top web or Tyvek lid of the product blister tray for part number MX140. If the display box shows part number 1176, the product is the correct Os Finder Cervical Dilator.

  • Brand
    CooperSurgical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for part number MX140 on the top web or Tyvek lid of the blister tray. If it shows 1176, the product is correct.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Jun 3, 202012. FDA classified it Class II: Jul 4, 202023. Published in FDA’s Enforcement Report: Jul 15, 202034. FDA terminated the recall: May 11, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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-2498-2020 (June 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2498-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA