Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference
Medical device recall Z-1837-2022. 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
- 56 US; 1033 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?
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G17542
56 US; 1033 OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
RPC-035145-0-5 G34131 UDI-DI: 00827002341319 Lot/Expiration Date: 14769270X 03-06-2025 14802181 20-06-2025 14816224 28-06-2025 14818488 29-06-2025 14818489 29-06-2025 14828627 06-07-2025 14828629 06-07-2025 RPC-035145 G18154 UDI-DI:…
Every code shown here, 1,372 characters
RPC-035145-0-5 G34131 UDI-DI: 00827002341319 Lot/Expiration Date: 14769270X 03-06-2025 14802181 20-06-2025 14816224 28-06-2025 14818488 29-06-2025 14818489 29-06-2025 14828627 06-07-2025 14828629 06-07-2025 RPC-035145 G18154 UDI-DI: 00827002181540 Lot/Expiration Date: 14770863 06-06-2025 14770864 06-06-2025 14813490 27-06-2025 14816227 28-06-2025 NS14770866 06-06-2025 NS14804982 21-06-2025 RPC-035145-5 G34132 UDI-DI: 00827002341326 Lot/Expiration Date: 14770872 06-06-2025 14810022 23-06-2025 14831440 07-07-2025 RPC-038145-0-5 G34129 UDI-DI: 00827002341296 Lot/Expiration Date: 14804972 21-06-2025 14809971 23-06-2025 RFSPC-038145-0 G17539 UDI-DI: 00827002175396 Lot/Expiration Date: 14809157 23-06-2025 14837048 12-07-2025 RFSPC-035145 G17540 UDI-DI: 00827002175402 Lot/Expiration Date: 14818484 29-06-2025 14818485 29-06-2025 14818490 29-06-2025 14840310 13-07-2025 RPC-038145-0 G18155 UDI-DI: 00827002181557 Lot/Expiration Date: 14819269 29-06-2025 14823406 01-07-2025 14832976 08-07-2025 NS14828649 06-07-2025 RPC-035145-0 G18153 UDI-DI: 00827002181533 Lot/Expiration Date: 14828625 06-07-2025 14828630 06-07-2025 14828635 06-07-2025 14828636 06-07-2025 14828637 06-07-2025 14828640 06-07-2025 14828641 06-07-2025 14841469 14-07-2025 NS14813479 27-06-2025 NS14818486 29-06-2025 RFSPC-035145-0 G17542 UDI-DI: 00827002175426 Lot/Expiration Date: 14844152 15-07-2025
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.”
- 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.