Boston Scientific Corporation recalls Rapid Refill Continuous Injection System
Reason for recall
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
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
- Rapid Refill Continuous Injection System, UPNM00566001299 affected lots3378661133825949338260263394991633968571339685753407998134153104
+291 more
341534133415341534203075342030773415341134203079342031153438660534386609343866133442965634429658345952493469355934616613346166153471243334763427347639673480572334805725348057293500699535006999350567933520894635186845352089503539731435208952353054363549803035448316354980283555152335626939355744633568811835688460358287143583170335848483358777683599528236049415361591943621988236294100363036143633223031177006311802063166627831329922313561073166627631798400317981333179813531798137318522463216245032208753322555263225552832496142326618703269604632696050326960523275269732773682327914753279147732820865328386123279147933119798329773463297734833030942331203203315800833158006333543113335431533354317334032483340325233696882336968843369688633696888337508833375088533750887363322323649726236159192365877043661226336739668367852153678521736814560368454863698388336983886372915923705947137417957374179593742980837456936374725233758574537627037376548923794147737974508380330213803302338124799381436353816521438182214382011233795918738353956383748333843020133968573343866113283861038205377384290543406620734429654346166113471242934763971348057273500699735448312354483143562693735688021358484813568739931616842316015733161684831616850316168463220875532455154358777663677685837037796372007063727622037291594376392383815438735305438317976143335431333696890364707893730967237396601374073233747252135056797356269333378661333825951339504223496521835056795361010203610041831356105322087593266186833030940336796503705947337041524376331573799164538137850383936093396856934703963363194813364986337019542374932753461660934386607347639693480572135942747318522443297735033354319378840433800194432752695371892803761293138703180344297003396856734017321345683063471243134873735348737373496542035007081351868433520894835397312354483103530560035626935357785153577851735778513359891203602767036049413363036123631948336312073363539513643701936517931364095463653738436622267367501173675011936994750369620143740732537456934377664803766097837764898377233763799164338856580381782143833785338326961384101113841429338576233385867893862211538633220386767783864949138680582388646913868730838876174389017023117092231601571316168443185224231852240321624483220875732696048327238723272387432838608329645503297734433119794331197963325746633334705334032503364986533933383
What the firm is doing
On June 30, 2026, the firm began notifying US customers via letters titled "Urgent Medical Device Removal - Immediate Action Required." Customers were instructed to immediately stop further use or distribution of affected product, and segregate it. Continue to follow the standard care when monitoring patients treated with the contact. Product is to be returned to Boston Scientific.
DistributionShow detailsHide
US Nationwide distribution. OUS consignee list pending.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2725-2026
- FDA device classification · KYZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.6960The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific 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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