Fixed Core Wire Guide (Straight), Guidewire Reference
Medical device recall Z-1834-2022. Published in FDA’s Enforcement Report on Oct 5, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 5, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 5,669 US; 5,286 OUS how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 TSF-25-145 G00617 TSF-32-145 G00638 C-SF-15-50 G02274 TSF-18-145 G00587 TSF-18-50 G00593 TSF-35-145 G00650 TSF-21-145 G00602 THSF-35-180 G01237 TSF-35-80 G00664 C-SF-25-30 G02163 C-SF-21-30 G02351 THSF-35-80 G02408
5,669 US; 5,286 OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
C-SF-18-30 G02261 UDI-DI: 00827002022614 Lot/Expiration Date: 14795056 15-06-2027 C-SF-25-40 G01937 UDI-DI: 00827002019379 Lot/Expiration Date: 14795057 15-06-2027 TSF-18-260 G00590 UDI-DI: 00827002005907 Lot/Expiration date: 14795061…
Every code shown here, 1,986 characters
C-SF-18-30 G02261 UDI-DI: 00827002022614 Lot/Expiration Date: 14795056 15-06-2027 C-SF-25-40 G01937 UDI-DI: 00827002019379 Lot/Expiration Date: 14795057 15-06-2027 TSF-18-260 G00590 UDI-DI: 00827002005907 Lot/Expiration date: 14795061 15-06-2027 C-SF-25-50 G01938 UDI-DI: 00827002019386 Lot/Expiration Date: 14795064 15-06-2027 TSF-35-180 G00652 UDI-DI: 00827002006522 Lot/Expiration Date: 14795595 15-06-2027 14795596 15-06-2027 14798673 16-06-2027 14821167 30-06-2027 14822385 30-06-2027 14835601 11-07-2027 C-SF-18-40 G02255 UDI-DI: 00827002022553 Lot/Expiration Date: 14797774 16-06-2027 TSF-25-145 G00617 UDI-DI: 00827002006171 Lot/Expiration Date: 14798256 16-06-2027 14802353 20-06-2027 14821721 30-06-2027 TSF-32-145 G00638 UDI-DI: 00827002006386 Lot/Expiration Date: 14798677 16-06-2027 C-SF-15-50 G02274 UDI-DI: 00827002022744 Lot/Expiration Date: 14802345 20-06-2027 TSF-18-145 G00587 UDI-DI: 00827002005877 Lot/Expiration Date: 14802352 20-06-2027 TSF-18-50 G00593 UDI-DI: 00827002005938 Lot/Expiration Date: 14807597 22-06-2027 TSF-35-145 G00650 UDI-DI: 00827002006508 Lot/Expiration Date: 14809677 23-06-2027 14809679 23-06-2027 14809680 23-06-2027 14821849 30-06-2027 14821850 30-06-2027 14821851 30-06-2027 14821852 30-06-2027 14821853 30-06-2027 14821854 30-06-2027 14821855 30-06-2027 14827347 05-07-2027 14827348 05-07-2027 14827349 05-07-2027 14827350 05-07-2027 14827351 05-07-2027 14827352 05-07-2027 14827353 05-07-2027 14827354 05-07-2027 14827355 05-07-2027 14827356 05-07-2027 14827357 05-07-2027 14833106 08-07-2027 14833107 08-07-2027 14833108 08-07-2027 14833109 08-07-2027 14833110 08-07-2027 14833117 08-07-2027 14836092 11-07-2027 14836093 11-07-2027 14836094 11-07-2027 14836097 11-07-2027 14836098 11-07-2027 14842387 14-07-2027 14845716 18-07-2027 14845717 18-07-2027 14845718 18-07-2027 14845724 18-07-2027 14845725 18-07-2027 14851622 20-07-2027 14851625 20-07-2027 14851626 20-07-2027 NS14841737 14-07-2027 TSF-21-145 G00602 UDI-DI: 00827002006027…
FDA’s list runs to 2,463 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Domestic distribution nationwide. Foreign distribution worldwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 16, 2022.
- FDA classified it on Sep 28, 2022.
- FDA’s Enforcement Report published it on Oct 5, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cook Incorporated, of Bloomington, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,463 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.