Galt Medical recall: Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP
Galt Medical Corporation is recalling Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP – 114,260 kits. The U.S. Food and Drug Administration published the recall on August 19, 2026; it began on June 26, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Share
| Product | Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP |
| Brand | Galt Medical |
| Company | Galt Medical Corporation |
| Type | Medical devices |
| Classification | Class II |
| Recall date | June 26, 2026 |
| Published by FDA | August 19, 2026 |
| Quantity | 114,260 kits |
| Recall ID | 99369 |
Recalled products
- 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
- FDA recall number
- Z-2917-2026
- Codes, lots and dates
- 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 G25294007 G25317082 G25318095 G25318096 G25318097 G25318094 G25318098 G25350169 G25350167 G25350170 G25353258 G25353259 G25350164 G22362193 G25350165 G25350171 G26016028 G26016029 G26016030 G26016031 G26016032 G26016033 G26016034 G26016035 G26044036 G26044039 G26044040 G26044041 G26044042 G26044043 G26044037 G26044038 G26099125 G26099126 G26099127 G26099128 G26099129 G26128429 G25252908 G25252909
- Quantity
- 114,260 kits
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99369
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Garland, TX, United States
Why it was recalled
The reason the FDA lists: “Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution in the state of MN.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99369, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other medical device recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I |
| Oct 7, 2026 | Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total | a fire hazard Most serious | FDA Class I |
| Oct 7, 2026 | Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II |
| Oct 7, 2026 | Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 units | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II |
| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Galt Medical Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP recalled?
Yes. Galt Medical Corporation recalled it on June 26, 2026; FDA published it August 19, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.