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Lower risk Medical device recall · FDA · Published February 23, 2022

Carefusion Endoscopes Recalled: Missing Instruction Manual

Carefusion recalls four endoscope models due to missing instruction manual in packaging. This could lead to improper use if the user doesn't know how to operate the device correctly.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0833-2022Medical deviceCarefusion ›
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Contact the company

Recalling firmCarefusion 2200 Inc75 N Fairway Dr · Vernon Hills, IL 60061-1845
✎ GovInfoNow plain-language explainer

Carefusion is recalling four specific endoscope models because the product packaging did not include the instruction manual. Without the manual, users may not know how to safely operate the device, which could lead to improper use. Read more at govinfonow.com/recall/61058-carefusion-endoscopes-recalled-missing-instruction-manual.

Source Summary by GovInfoNow · govinfonow.com/recall/61058-carefusion-endoscopes-recalled-missing-instruction-manual · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0833-2022

Cite this page

“Carefusion Endoscopes Recalled: Missing Instruction Manual.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61058-carefusion-endoscopes-recalled-missing-instruction-manual. Based on FDA recall #Z-0833-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0833-2022%22&limit=1).

The FDA announced on Feb. 23, 2022, that CareFusion 2200 Inc recalled specific Endoplastic Endoscopes and fittings because their finished device packages lacked the Instructions for Use (IFU).

How to tell if you have it

  • CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910
  • CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920
  • CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #88-9808
  • CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809

The hazard

The hazard is that the finished device package did not contain the IFU.

Context

GovInfoNow's records show Carefusion 2200 Inc has 8 other recalls on record since 2013-12-20. Other recent recalls of similar products include Endoscopic Surgical Device Cracking Risk (2023-07-13), Vaginal Specula Recalled Due to Label Mismatch (2023-03-16), and Genesis Reusable Sterilization Containers May Contaminate Surgical Equipment (2023-01-30). Other recent recalls of similar products include Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall: Safety Hazard (2026-03-25), HEMOSPRAY Endoscopic Hemostat Recall: Endoscope Adherence Issues (2026-08-20), and W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall: Incorrect Labeling Risk (2026-05-22).

How to tell if you have this one

Check for the specific model numbers and catalog codes listed in the recall. The affected items include CareFusion Snowden-Pencer endoscopes with catalog numbers 88-5910, 88-5920, 88-9808, and 88-9809.

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

What to do — step by step

  1. Check for Missing Manual

    Ensure the product packaging includes the instruction manual. If it does not, contact Carefusion for further instructions.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 23 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, IN, LA, MA, MI, MN, MS, MT, NC, NY, OH, OK, PA, TN, TX, VA, and WI. The countries of Taiwan and Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Montana, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

1. Firm started the recall: Feb 23, 202212. FDA classified it Class II: Mar 30, 202223. Published in FDA’s Enforcement Report: Apr 6, 202234. FDA terminated the recall: May 2, 2023420222023
  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-0833-2022 (February 23, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0833-2022 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