Galt Medical Corporation recalls Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-0…
Reason for recall
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 StopcockUDIUDI 00841268107250/Lot237 affected lotsG22171212G22201213G22201214G22201215G22201216G22201217G22201218G22234219
+229 more
G22234220G22262227G22234221G22234222G22234223G22262225G22234224G22262226G22262228G22262229G22262230G22292231G22292232G22292233G22292234G22292235G22292236G22292237G22320238G22320239G22320240G22320241G22320242G22320243G22320244G22354191G22362192G22362194G22362195R23083454G23076104G23076105G23083106G23083107G23083108G23083109G23111110G23111111G23111112G23111113G23111114G23111115G23146116G23146117G23146118G23146119G23146121G23146120G23174122G23174123G23174124G23174125G23174126G23174127G23202128G23202129G23202130G23202131G23202132G23202133G23237134G23237135G23094468G23237136G23237137G23237138G23237139G23237159G23265140G23265141G23265142G23265143G23265144G23265145G23293146G23293147G23293148G23293149G23293150G23293151G23328152G23328153G23328154G23328156G24110621G24110621G24113622G24113623G24113625G24113626G24113624G24036110G24036113G24036111G24036111G24036112G24064115G24064118G24064118G24064116G24064116G24064117G24064119G24064119G24064120G24064121G24064122G24092123G24178931G24092126G24092127G24092128G24092129G24127485G24092125G24092124G24127486G24127487G24127488G24127489G24127490G24127491G24155492G24155493G24155494G24155494G24155495G24155496G24155497G24155498G24190499G24190500G24190501G24190502G24190503G24190504G24190505G24190506G24218507G24218512G24218509G24218510G24337696G24337697G24218508G24337698G24218511G24246514G24246515G24246513G24246517G24246518G24281519G24281521G24281520G24281522G24281523G24246516G24337699G24281524G24281525G24281526G24281527G24309528G24309529G24309530G24309532G24309531G24309533G24309534G24309535G24337700G24337701G24337702G24337703G24337704G25001012G25008017G25008013G25008014G25008015G25008018G25008016G25008019G25252905G25252907G25252906G25273965G25252910G25294007G25317082G25318095G25318096G25318097G25318094G25318098G25350169G25350167G25350170G25353258G25353259G25350164G22362193G25350165G25350171G26016028G26016029G26016030G26016031G26016032G26016033G26016034G26016035G26044036G26044039G26044040G26044041G26044042G26044043G26044037G26044038G26099125G26099126G26099127G26099128G26099129G26128429G25252908G25252909
What the firm is doing
On July 30, 2026, Galt Medical Issued a 4th iteration of the Urgent: Medical Device Recall Notification via Email expanding the affected lots. The initial notification was issued on June 26, 2026 via Email, 2nd notification issued on June 30, 2026 and 3rd notification issued on July 9, 2026. Galt Medical asked consignees to take the following actions 1. Discontinue use and distribution of the products with the affected lot numbers. 2. Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers. 3. Ensure all applicable personnel within the vicinity of device activation carefully read the content of this notification. If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification 4. Complete the enclosed Field Correction Reply Forms and email or fax them to the attention of the Corrections Coordinator at quality@galtmedical.com or 214-778-1433. 5. For additional details, see recall notification.
DistributionShow detailsHide
US Nationwide distribution in the state of MN.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2917-2026
- FDA 510(k) clearance · K000737The device's official FDA premarket clearance record
- FDA 510(k) clearance · K021990The device's official FDA premarket clearance record
- FDA device classification · DQXOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1330The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Galt Medical CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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