Boston Scientific Enhance Transcarotid/Peripheral Access Kit
Medical device recall Z-2917-2026. Published in FDA’s Enforcement Report on Aug 19, 2026.
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 Aug 19, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 114,260 kits 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?
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
114,260 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI:00841268107250/Lot: G22171212 G22201213 G22201214 G22201215 G22201216 G22201217 G22201218 G22234219 G22234220 G22262227 G22234221 G22234222 G22234223 G22262225 G22234224 G22262226 G22262228 G22262229 G22262230 G22292231 G22292232…
Every code shown here, 1,994 characters
UDI:00841268107250/Lot: G22171212 G22201213 G22201214 G22201215 G22201216 G22201217 G22201218 G22234219 G22234220 G22262227 G22234221 G22234222 G22234223 G22262225 G22234224 G22262226 G22262228 G22262229 G22262230 G22292231 G22292232 G22292233 G22292234 G22292235 G22292236 G22292237 G22320238 G22320239 G22320240 G22320241 G22320242 G22320243 G22320244 G22354191 G22362192 G22362194 G22362195 R23083454 G23076104 G23076105 G23083106 G23083107 G23083108 G23083109 G23111110 G23111111 G23111112 G23111113 G23111114 G23111115 G23146116 G23146117 G23146118 G23146119 G23146121 G23146120 G23174122 G23174123 G23174124 G23174125 G23174126 G23174127 G23202128 G23202129 G23202130 G23202131 G23202132 G23202133 G23237134 G23237135 G23094468 G23237136 G23237137 G23237138 G23237139 G23237159 G23265140 G23265141 G23265142 G23265143 G23265144 G23265145 G23293146 G23293147 G23293148 G23293149 G23293150 G23293151 G23328152 G23328153 G23328154 G23328156 G24110621 G24110621 G24113622 G24113623 G24113625 G24113626 G24113624 G24036110 G24036113 G24036111 G24036111 G24036112 G24064115 G24064118 G24064118 G24064116 G24064116 G24064117 G24064119 G24064119 G24064120 G24064121 G24064122 G24092123 G24178931 G24092126 G24092127 G24092128 G24092129 G24127485 G24092125 G24092124 G24127486 G24127487 G24127488 G24127489 G24127490 G24127491 G24155492 G24155493 G24155494 G24155494 G24155495 G24155496 G24155497 G24155498 G24190499 G24190500 G24190501 G24190502 G24190503 G24190504 G24190505 G24190506 G24218507 G24218512 G24218509 G24218510 G24337696 G24337697 G24218508 G24337698 G24218511 G24246514 G24246515 G24246513 G24246517 G24246518 G24281519 G24281521 G24281520 G24281522 G24281523 G24246516 G24337699 G24281524 G24281525 G24281526 G24281527 G24309528 G24309529 G24309530 G24309532 G24309531 G24309533 G24309534 G24309535 G24337700 G24337701 G24337702 G24337703 G24337704 G25001012 G25008017 G25008013 G25008014 G25008015 G25008018 G25008016 G25008019 G25252905 G25252907 G25252906 G25273965 G25252910…
FDA’s list runs to 2,393 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.
US Nationwide distribution in the state of MN.
The states and territories these words name
- Minnesota
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.
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 Jun 26, 2026.
- FDA classified it on Aug 7, 2026.
- FDA’s Enforcement Report published it on Aug 19, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Galt Medical Corporation, of Garland, TX.
- 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 2,393 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.