Recall archive / FDA device enforcement

GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery ... — FDA record Z-0983-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 4, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier Edition, SIGNA Artist, Optima MR450w 1.5T, Optima MR450w GEM, Discovery MR450 1.5T, GE 1.5T and 3.0T SIGNA HDx, GE 1.5T and 3.0T SIGNA HDxt, 1.5T and 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant, SIGNA 1.5T TwinSpeed, SIGNA Infinity Excite, SIGNA Infinity with Excite Technology, SIGNA OpenSpeed, SIGNA HFO, SIGNA HFO/I MR System, GE 0.7T SIGNA OpenSpeed, SIGNA OpenSpeed with Excite, SIGNA HDe, Brivo MR355, Optima MR360, SIGNA 3.0T MR System, SIGNA Excite 3T, 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD, SIGNA Contour, SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, HighSpeed Plus, MR Vectra, MR MAX, Optima MR430s, Optima MR430s 1.5T, Optima MR430s MRI Scanner, 1.0T MSK Extreme, SIGNA Profile EXCITE, SIGNA Ovation, 0.35T SIGNA Ovation with Excite, SIGNA Prime.
Reason: During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
Classification: Class II
Recalling firm: GE Healthcare, LLC
Quantity: 18,411 systems
Agency-reported status: Ongoing
Source record identifier: Z-0983-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	All GE Healthcare MR Systems. UDIs: 01008148480204781120092321QED3257; 01008148480204851119053021QED2493; 010088483808097321301223488; 010088483808097321301408170; (01)00846082115971(11)160923921)PG45; 01008148480200031117031321QED1184; 01008148480200031117052221QED1241; 01008148480200031117061221QED1268; 01008148480200031117082921QED1348; 01008148480200031118061521QED1775; 01008148480200031118072621QED1888; 01008148480200031118110721QED2090; 010081484802000311120010221QED2892; 010081484802000311120090121QED3227; 01008148480208071921QED1881; 01008148480202491118091321QED1990; 01008148480202491118110121QED2080; 01008148480202491119021421QED2282; 01008148480202491119022121QED2296; 01008148480202491119061321QED2525; 01008148480202491119062821QED2548; 01008148480202491119080121QED2598; 01008148480202491119082921QED; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111. US System ID numbers: 3422, 00506MRS01, 030022MR01, 1000000047, 1000000576, 1000001238, 1000001348, 1000002760, 1000004048, 1000004074, 1000004278, 1000004288, 1000004456, 1000004458, 1000004646, 1000004953, 1000004954, 1000004956, 1000004986, 1009000, 1118313, 1323566, 201261MR, 201418MR2, 201445750W, 201447MRW, 201456MRX, 201579MRW, 201632MR, 201634MRW, 201639MR3T, 201669MR2, 201730MR, 201773MR, 201836MRW, 201840MR, 201858MRW, 201871MR, 201894GEMR, 201967MR, 202223MR, 202269MR, 202476MR2, 202476MR4, 202476MR5, 202715MR2, 202715MR3, 202865MR3T, 202966MR3TW, 203276ART, 203276MR, 203319MR, 203325MR4, 203325MR450W, 203327MR3T, 203337MREXP, 203453MR1, 203453VOYAGER, 203574MR450W, 203576MR2, 203694MR3T, 203739DDI3T, 203739MR450W, 203834VOYAGER, 203837MR450W, 203855MR3T, 203863MR450W, 203949MR3T, 205206MR1, 205251MR1, 205280MR1, 205295MR1, 205333MR1, 205345MRI, 205428MR, 205450WSMR, 205460SMR1, 205486MR1, 205487MR2, 205592450W, 205592750, 205608MR, 205702450W, 205750MR6, 205783450W, 205801KMR3, 205814MR1, 205822MR1, 2058773T, 205877450W, 205877MR2, 205933MRI1, 205934CVMR, 205939450W, 205939MR2, 205949MR450W, 205991MR2, 2059953T, 205995MRI, 205LMK450W, 205SBMR, 206223VM750W, 206223VMR1, 206244HM450, 206244HMR2, 206288SCCMR, 206292SR750W, 2063203TMR, 206373MR, 206386SMR, 206744HMR, 206762VAMR, 206781SB750W, 207255HD16MR, 207338MR450W, 207778ARTIST, 207945MR750, 207INTERMEDDVMR, 207MIDCOASTMR, 207MMCSMR, 207OA430MR, 208265BGMR, 208367LX10C, 208367LX11, 208367LX12, 208367LX14, 208367LX4, 208367LX6, 208367LX7, 208367LX8, 208367LX9, 208373MR, 208422MR1, 208463SZMR, 208529MR1, 208557MRI, 208678MR, 208743ART, 208743LOAMR, 208785MR, 208882MR450W, 209225VC750, 209333MR, 209491SSMR, 209521SGMR, 209526KMR, 209526SMMR, 209536SMR, 209577MRMR, 209754MR, 209832MR, 209847ONI, 209952SGMR, 209EMR, 209LBMR, 209MTMR, 209SJMR, 209SUTAMDMR, 210208MOMR, 210297SLMR, 210351HDMR, 210545SOMR, 210572CIMR, 210590NEHDMR, 210614NWMRLX, 210616MRLX, 210617HUBMR, 210617TCAMR2, 210681MSWHMR, 210737MR, 210804SUNMR, 210921GMR, 210921SWGMR, 210974NCBMR, 210ALMRI, 210BAMCMR1, 210LAFB750, 210MSMTMR, 210MSNWPMR, 210MSSPMR, 210OICRV, 210VHSART, 210WHASCMR2, 212255MR, 212288GE3T, 212288GEMR2, 212305MR5, 212312MR, 212420MR2, 212477MR, 212523MR3, 212523MRLX, 212535MR1, 212543PREMIER, 212562MR1, 212722HDXMR1, 21277MR1, 212844MRP, 212860EXTMR, 212989MR1, 212HDX2, 213202MR, 213340MR, 213387MR, 213426MR1, 213748HDMR, 213777MR, 213825DVMR4, 213829MR2, 213977MR, 213977MR2, 214214ABSMR1, 214220WBCMR1, 214265MINVMR1, 214265TXOMR1, 214266PCBCMR1, 214276MR1, 214302PDWMR1, 214329PHIMR1, 214341PDDMR2, 214341PDGPMR1, 214369TMR, 214369TSMR1, 214420MR1, 214433TNMR, 214559SRHMR1, 214619LSFMR1, 214645UT3TMR1, 214742VAMR1, 214794WMR1, 214820IMR1, 214820TS750WMR, 214820TSJMR2, 214828MPMR1, 214879INVIVO, 214947LXMR2, 214947MR2, 215111MR, 215201MR, 215248HD, 215277MRP, 215291LX, 215322MR2, 215331LXMR, 215453MR, 215464MR, 215481MR, 215543MR1, 215612HD, 215662MRA, 215663HD, 215674OP450W, 215707VOYAGER, 215750MR, 215829MR1, 215836LX, 215879MR, 215949MR, 215952LX, 215955MR3, 215955MR3G, 215997MR2, 215ARIA450W, 215DOY430S, 215FCCCMR3T, 215JEANESMR, 215VETMR, 216362MR, 216739MR3T, 216841MR, 216944MR2, 217223BHMR, 217258PMR, 217258SBMR2, 217347SAMR1, 217366CMR1, 217383CMR1A, 217383EDMR, 217528MR1, 217528MR2, 217532DVMR, 217732LMR, 217753MR1, 217753SMR1, 217876FMR, 217876MR2, 217BHC450W, 217QMG3TMR, 217QMGVOYAGER, 218249ART15, 2187493T, 218828MR, 219326MR450W, 219356MR, 219435MR, 219736SLMR2, 219738DVMR, 219756PHMR, 219845MR, 219865MRI, 219877MR, 219LBJMR, 224287MR, 224470MR, 225261MR, 225298MR, 225381MR, 225658LMR, 225751PROMR, 225755MRI, 225761MR2, 225763MR, 225763MR2, 225769BRCMR, 225769MRI, 225BRIMR, 225ICL450W, 225OHGMRI, 225OPMR, 225SJMR, 2277, 228818DVMR, 228BIENDVMR, 228CDLKMR, 229226PMR, 229228450W, 229228ARTIST, 229276MR, 229312MMRI, 229336MOB1, 229377MR1, 229386MR1, 229888AMR, 239254MR, 239292MR1, 239307MR, 239458MR1, 239482PRO, 239768MR, 239936MR, 239AHCMR, 239MEIMR1, 239NHVOY, 239VA450MR, 240215MR, 240296MR3T, 240313MR, 240420750W, 240480MR, 240555AMR2, 240566MR2, 240683MR, 240707MR3T, 248465MR3T, 248533750W, 248543MR, 2486613TMR, 248849MR3T, 248898MR450, 2489643T, 251435MR15T, 251450MR, 251476MR, 251621450W, 251639MR3T, 251867MR1, 251EMIMR1, 251SARAMR, 252209RCMR, 252436MPMR, 252482MR450, 252OBXMR, 252VBART, 252VMC3T, 253219RMR, 2533, 253395AMR, 253445MR, 253474MR, 253596GHTMR, 253761CMMR, 253833CMR, 253841NSMR, 254562MR450W, 254751PMR1, 254965CTOMR1, 254IDEALMRI, 256235SMR, 256329MR2, 256332HFO, 256350MR1, 256357WLXMR, 256386AV450, 256386HKMR, 256543MR, 256571MR450W, 256734MR3T, 256761MR1, 256764ECMMR, 256840MR450W, 256880MR1, 256881MR1, 256891MRI, 256973MR450, 256997MRI, 256ALOPMR, 256ASURGMR1, 256CCIMR1, 256GMTMR450W, 256HICMR2, 256MHMR1, 256ODCMR1, 256SPCMR, 256SPMR2, 256SRIPM450, 256TICMR1, 260266750W, 260266MR, 260347MR, 260373MR, 260425MR, 260426VAMR, 260463MR, 260469FCMR, 260563450W, 260665MR, 260824MR, 260920MR, 262243MR1, 262289MR1, 262303MR1, 262363MR1, 262395MR1, 262542MR1, 262544MR1, 262656MR1, 262697MR1, 262785MR1, 262891MR1, 2647, 267985MR, 269341MR3T, 269342MR3T, 269342MR3T2, 269556MR, 269945MR, 269979VOY, 269DVMR, 270251JPMR, 270441LMR, 270444LMR1, 270527MMR, 270688MR2, 270692MRHDE, 270793HDE, 270798HDMR, 270825MR1, 2709263HD, 270965MR1, 272639MR, 276228MR, 276236MR450, 276596450W, 276666MR450W, 281207MR, 281242MR, 281274MR2, 281312MHSHMR, 281333MR1, 281338MR2, 281341MR1, 281348450WMR, 281364HDMR, 281364MR2, 281367MR1, 281420HSMR1, 281440KSFMR, 281477MR2, 281558MR1, 281579KRMR2, 281588MR1, 281637MR1, 281758MR355, 281837MR1, 281840SIGNA, 281879MR, 281880KSFMR1, 281943MR450, 281955MR, 281997MR1, 281AVSMR1, 281BAY450MR1, 281HMI750W, 281HORMR1, 281KELSEYMR1, 281NWARTIST, 281OAKMR1, 281SMCMR1, 281WLMR1, 28859THMR, 3000158, 3003710, 3003856, 3005097, 3008010, 3011062, 3012383, 301279MR3, 301279MR4, 301295MR3T2, 301295MR4, 301459MR, 3014643TMR, 301464MR, 301496MR3T4, 301496MR3T6MR, 301496PETMR, 301548MR, 301570MR, 301609MR, 301637MR, 3016508, 301677MR, 3016808, 301698MR1, 301723MR450W, 301759MR, 301782MR, 301868MR1, 302430MR, 302430MR750W, 302575MR, 302623MR, 302629MR, 302655MR1, 302733MR3T, 302734MR, 302744MR, 302744MR750, 302993MR, 302999MR, 303269MR, 303278MR, 303320MR2, 303338MR1, 303340MR, 303341MR, 303355MR, 303365MR, 303416MR, 303426MR, 303427MR2, 303427MRW, 303433MR, 303436MR, 303444MR, 303446MR, 303451MR, 303466MR, 303467MR, 3034682202MR, 303492MR, 303493MR, 303498MR1, 303577DVMR2, 303604MR2, 303633MR, 303651MR, 303662MR, 303673MR, 303678MR, 303689MR, 303695MR, 303699MR2, 303730MR, 303741TMR, 303761MR, 303762MR, 303789MR, 303794MR, 303837MR1, 303839MR1, 303861KFMR2, 303866MR, 303870MR, 3038998MR, 303933MR1, 303964MR, 303SKYMR3, 303SMIMR1, 304255MR1, 304255VMR, 304255VMR2, 304256MR2, 304269MRI, 304293MR3T, 304347MR1, 304367MR450W, 304429MR1, 304526CMR2, 304526SMR1, 304528MR1, 304636MR, 304647GMR, 304766MR1, 304831MR, 304831MR1, 305223MR2, 305223MR3, 305243MR1, 305256MR1, 305261MR1, 305264MR1, 305275MR1, 305295MR1, 305421MR1, 305445MR1, 3055140, 305592MR1, 305642MR1, 305665MR450W, 305667MR1, 305682MR1, 305696MR450W, 305820MR1, 305823MR3, 305825MR1, 305828MR1, 305835MR450W, 305854MR1, 305933MR1, 305CMISOUTH, 305CVMSMR1, 307352MR, 307382FRONTMR, 307382MR2, 307578MR, 307634MR, 307674SOMR, 307733MR, 307745MR1, 307789MR, 307BHBBJ3T, 307FRMIMR, 307FRMIMR2, 307PBJCASMR, 307PBJCHEYMR, 307SUMMITMR, 307SWRMR, 308255MR, 308284MR, 308398HDMR, 308432MR, 308995PMR, 308PVMR, 309353PMR, 309661CINFMR1, 3096653TMR, 309672MR450W, 309683MNMR750, 309691MR, 309691P450W, 310257MR1, 310264MR, 310289MR, 310301MR, 310316MR, 310358MR3, 310358VMR, 310478MR2, 310532MR, 310623MR, 3106573TMR, 310671MR, 310740MR, 310806MR2, 310832MR, 3109, 310943MR, 312227750WMR, 312355CVMR, 312355DVMR, 312355MR9TC, 312471MR, 312702KMR3T, 312702MR3T, 312702MR450, 312770SMR, 312942CMR2, 312947MR, 312996MR3T, 312CCHMR2, 313294MOB2, 313294MR, 313593MR3T, 3137453TMR, 313745ART1, 313745DMCMR, 313791MRM, 313916PREMIER, 313916PREMIER2, 314251MMR2, 314344CDIMR1, 314432CDIMRF, 314434LWMR1, 314467SJSMR1, 314525MCCMR, 314525SAMR, 314543SAMR1, 314567BRMR, 314577CGMR3T, 314644IMR1, 314743AMR, 314768MR, 314849MEDFMR, 314EMERSONMR, 315338HDX, 315393HDMR, 315425VAMR, 315452NORTH, 315470MR, 315792MR, 315823MR, 315922MR, 315CNYCLAYMR, 315LCGHMR, 315MDR2POB, 315MDRBRIT, 315MDREAST_DEL, 315MDRRADISSON, 315MDRSTJOES, 315ORTHOEASTMR, 315SOS450W, 315SOSNORTH, 315UBJARCH, 315UBJART, 316262MR450, 316268MR, 316268TWIN3, 316688WMR, 316689MR, 316689WCMR1, 316858MR450, 317204MR1, 317228MR1, 3173383T1, 317344MR1, 317415MR2, 317582MR2, 317745MR3, 317834MR1, 317851MR1, 317865HDE, 317865MR3, 317865MR360, 317874MR1, 317887MR2, 317887MR3, 317888MR1, 317899MR, 318214MR, 318254MR, 318329MR, 318330MR, 318336MR1, 318371MR, 318386MR, 318425HFO, 318442CMR1, 318443MR2, 318448MR, 318675LMR2, 318681CBMR, 318769MR, 318798450W, 318798MR, 318812HDMR, 318869MR, 319268MR, 319335MR2, 319768GRMR1, 320255VOY, 320257MR1, 320523MR1, 320589MR, 320693MR, 321207MR, 321434MR2, 321CLMRVOY, 321FCMR1, 321MR3T2, 321MR3T3, 321WLMR, 321WMC450W, 323268MR2, 323294VMR, 323374MR, 323441MR1, 323442MR1, 323442MR3, 323648MR, 323669MR, 323724MRPRO, 323932MR1, 325307HPMR, 325574MRV, 325670ICMR, 330263450W, 330334MR, 330342MR, 330344MR750W, 330363450W, 330363MR, 330385MR, 330489MR450W, 330535MR2, 330729HDE, 330729MR, 330746MR, 330757MR, 330830MR, 330834GSMR, 330841MR, 330896MR, 330945MR, 331216MR, 333NFMR2, 334222MR, 334244MR, 334273CIC750W, 334277SIS, 334286BMR2, 334287MR, 334347MR, 334358MR2, 334418450W, 334636MR, 334676450W, 334684MOB1, 334699MR, 334732HDMR, 334732MR, 334826450W, 336397P3T, 336503PMMR, 336625DVMR, 336719MR, 336719MRI, 336760DVMR, 336765MR1, 336832MR1, 336832WMR1, 337237MR1, 337261MR1, 337289MR1, 337363MR450, 337365MR1, 337367MR1, 337521MR1, 337531MR, 337560MR1, 337580MR1, 337593MR2, 337898MR1, 337943MR1, 337981MR1, 352237MR1, 352265MR1, 352333NFMR1, 352336MR1, 352344MR2, 352344MR3, 352401MR, 352521MR1, 352564MR, 352596MR, 352597MR1, 352620MR1, 352684MR, 352746MR, 352867MR2, 352871MR, 352VAMR1, 352VAMR3T, 352WATOUT, 3591, 3600, 360236MR1, 360254NMR1, 360397MR2, 360425MR1, 360449MR1, 360487MR2, 360571MR1, 360577MR1, 360582450WPA, 360582MR2, 360636MR1, 360692WSMR, 360696MR1, 360744HM450MR, 360754MRCM, 360786ONIMR, 361275PIONMR, 361570LXMR, 361572CICMR, 361887CMR, 361ORTHOMR, 370MR, 386362MR, 386385MR1, 386860LXMR, 386917MR, 386AIMR, 386FHDMR, 386FHPCMR3T, 386FMR3T, 386FNSBMR3T, 386HPOMR, 401331MR, 401333RIMR, 401348MR1, 401444MR3T, 402219MR3T, 402228MR, 402336MR, 402362DVMR, 402375HDE, 402384MNMR, 402463MR, 402484MR, 402572MR, 402778OWMR1, 402873NEBMR, 402879MR, 402926NHI, 402VCAMR, 403152, 404256AMR1, 404256OMR, 404296MR, 404297DOMR, 404297UMR, 404299AMR, 404325WMR, 4043503TMR, 404351MR, 404352PNC, 404355POCMR, 404605MR, 404605PKMR, 404772NMR3T, 404778MR, 404778MR1, 404778PETMR, 405224GHDE, 405271EMR, 405271OUCMR, 405271PMR1, 405271UMR, 405272SMR, 405273PMR, 405307NHD, 405307NMR, 405340MR, 405350MR, 405359EMR, 405375MMR, 405...

Label field

Details supplied by the agency

Lot, code or applicability

All GE Healthcare MR Systems. UDIs: 01008148480204781120092321QED3257; 01008148480204851119053021QED2493; 010088483808097321301223488; 010088483808097321301408170; (01)00846082115971(11)160923921)PG45; 01008148480200031117031321QED1184; 01008148480200031117052221QED1241; 01008148480200031117061221QED1268; 01008148480200031117082921QED1348; 01008148480200031118061521QED1775; 01008148480200031118072621QED1888; 01008148480200031118110721QED2090; 010081484802000311120010221QED2892; 010081484802000311120090121QED3227; 01008148480208071921QED1881; 01008148480202491118091321QED1990; 01008148480202491118110121QED2080; 01008148480202491119021421QED2282; 01008148480202491119022121QED2296; 01008148480202491119061321QED2525; 01008148480202491119062821QED2548; 01008148480202491119080121QED2598; 01008148480202491119082921QED; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111. US System ID numbers: 3422, 00506MRS01, 030022MR01, 1000000047, 1000000576, 1000001238, 1000001348, 1000002760, 1000004048, 1000004074, 1000004278, 1000004288, 1000004456, 1000004458, 1000004646, 1000004953, 1000004954, 1000004956, 1000004986, 1009000, 1118313, 1323566, 201261MR, 201418MR2, 201445750W, 201447MRW, 201456MRX, 201579MRW, 201632MR, 201634MRW, 201639MR3T, 201669MR2, 201730MR, 201773MR, 201836MRW, 201840MR, 201858MRW, 201871MR, 201894GEMR, 201967MR, 202223MR, 202269MR, 202476MR2, 202476MR4, 202476MR5, 202715MR2, 202715MR3, 202865MR3T, 202966MR3TW, 203276ART, 203276MR, 203319MR, 203325MR4, 203325MR450W, 203327MR3T, 203337MREXP, 203453MR1, 203453VOYAGER, 203574MR450W, 203576MR2, 203694MR3T, 203739DDI3T, 203739MR450W, 203834VOYAGER, 203837MR450W, 203855MR3T, 203863MR450W, 203949MR3T, 205206MR1, 205251MR1, 205280MR1, 205295MR1, 205333MR1, 205345MRI, 205428MR, 205450WSMR, 205460SMR1, 205486MR1, 205487MR2, 205592450W, 205592750, 205608MR, 205702450W, 205750MR6, 205783450W, 205801KMR3, 205814MR1, 205822MR1, 2058773T, 205877450W, 205877MR2, 205933MRI1, 205934CVMR, 205939450W, 205939MR2, 205949MR450W, 205991MR2, 2059953T, 205995MRI, 205LMK450W, 205SBMR, 206223VM750W, 206223VMR1, 206244HM450, 206244HMR2, 206288SCCMR, 206292SR750W, 2063203TMR, 206373MR, 206386SMR, 206744HMR, 206762VAMR, 206781SB750W, 207255HD16MR, 207338MR450W, 207778ARTIST, 207945MR750, 207INTERMEDDVMR, 207MIDCOASTMR, 207MMCSMR, 207OA430MR, 208265BGMR, 208367LX10C, 208367LX11, 208367LX12, 208367LX14, 208367LX4, 208367LX6, 208367LX7, 208367LX8, 208367LX9, 208373MR, 208422MR1, 208463SZMR, 208529MR1, 208557MRI, 208678MR, 208743ART, 208743LOAMR, 208785MR, 208882MR450W, 209225VC750, 209333MR, 209491SSMR, 209521SGMR, 209526KMR, 209526SMMR, 209536SMR, 209577MRMR, 209754MR, 209832MR, 209847ONI, 209952SGMR, 209EMR, 209LBMR, 209MTMR, 209SJMR, 209SUTAMDMR, 210208MOMR, 210297SLMR, 210351HDMR, 210545SOMR, 210572CIMR, 210590NEHDMR, 210614NWMRLX, 210616MRLX, 210617HUBMR, 210617TCAMR2, 210681MSWHMR, 210737MR, 210804SUNMR, 210921GMR, 210921SWGMR, 210974NCBMR, 210ALMRI, 210BAMCMR1, 210LAFB750, 210MSMTMR, 210MSNWPMR, 210MSSPMR, 210OICRV, 210VHSART, 210WHASCMR2, 212255MR, 212288GE3T, 212288GEMR2, 212305MR5, 212312MR, 212420MR2, 212477MR, 212523MR3, 212523MRLX, 212535MR1, 212543PREMIER, 212562MR1, 212722HDXMR1, 21277MR1, 212844MRP, 212860EXTMR, 212989MR1, 212HDX2, 213202MR, 213340MR, 213387MR, 213426MR1, 213748HDMR, 213777MR, 213825DVMR4, 213829MR2, 213977MR, 213977MR2, 214214ABSMR1, 214220WBCMR1, 214265MINVMR1, 214265TXOMR1, 214266PCBCMR1, 214276MR1, 214302PDWMR1, 214329PHIMR1, 214341PDDMR2, 214341PDGPMR1, 214369TMR, 214369TSMR1, 214420MR1, 214433TNMR, 214559SRHMR1, 214619LSFMR1, 214645UT3TMR1, 214742VAMR1, 214794WMR1, 214820IMR1, 214820TS750WMR, 214820TSJMR2, 214828MPMR1, 214879INVIVO, 214947LXMR2, 214947MR2, 215111MR, 215201MR, 215248HD, 215277MRP, 215291LX, 215322MR2, 215331LXMR, 215453MR, 215464MR, 215481MR, 215543MR1, 215612HD, 215662MRA, 215663HD, 215674OP450W, 215707VOYAGER, 215750MR, 215829MR1, 215836LX, 215879MR, 215949MR, 215952LX, 215955MR3, 215955MR3G, 215997MR2, 215ARIA450W, 215DOY430S, 215FCCCMR3T, 215JEANESMR, 215VETMR, 216362MR, 216739MR3T, 216841MR, 216944MR2, 217223BHMR, 217258PMR, 217258SBMR2, 217347SAMR1, 217366CMR1, 217383CMR1A, 217383EDMR, 217528MR1, 217528MR2, 217532DVMR, 217732LMR, 217753MR1, 217753SMR1, 217876FMR, 217876MR2, 217BHC450W, 217QMG3TMR, 217QMGVOYAGER, 218249ART15, 2187493T, 218828MR, 219326MR450W, 219356MR, 219435MR, 219736SLMR2, 219738DVMR, 219756PHMR, 219845MR, 219865MRI, 219877MR, 219LBJMR, 224287MR, 224470MR, 225261MR, 225298MR, 225381MR, 225658LMR, 225751PROMR, 225755MRI, 225761MR2, 225763MR, 225763MR2, 225769BRCMR, 225769MRI, 225BRIMR, 225ICL450W, 225OHGMRI, 225OPMR, 225SJMR, 2277, 228818DVMR, 228BIENDVMR, 228CDLKMR, 229226PMR, 229228450W, 229228ARTIST, 229276MR, 229312MMRI, 229336MOB1, 229377MR1, 229386MR1, 229888AMR, 239254MR, 239292MR1, 239307MR, 239458MR1, 239482PRO, 239768MR, 239936MR, 239AHCMR, 239MEIMR1, 239NHVOY, 239VA450MR, 240215MR, 240296MR3T, 240313MR, 240420750W, 240480MR, 240555AMR2, 240566MR2, 240683MR, 240707MR3T, 248465MR3T, 248533750W, 248543MR, 2486613TMR, 248849MR3T, 248898MR450, 2489643T, 251435MR15T, 251450MR, 251476MR, 251621450W, 251639MR3T, 251867MR1, 251EMIMR1, 251SARAMR, 252209RCMR, 252436MPMR, 252482MR450, 252OBXMR, 252VBART, 252VMC3T, 253219RMR, 2533, 253395AMR, 253445MR, 253474MR, 253596GHTMR, 253761CMMR, 253833CMR, 253841NSMR, 254562MR450W, 254751PMR1, 254965CTOMR1, 254IDEALMRI, 256235SMR, 256329MR2, 256332HFO, 256350MR1, 256357WLXMR, 256386AV450, 256386HKMR, 256543MR, 256571MR450W, 256734MR3T, 256761MR1, 256764ECMMR, 256840MR450W, 256880MR1, 256881MR1, 256891MRI, 256973MR450, 256997MRI, 256ALOPMR, 256ASURGMR1, 256CCIMR1, 256GMTMR450W, 256HICMR2, 256MHMR1, 256ODCMR1, 256SPCMR, 256SPMR2, 256SRIPM450, 256TICMR1, 260266750W, 260266MR, 260347MR, 260373MR, 260425MR, 260426VAMR, 260463MR, 260469FCMR, 260563450W, 260665MR, 260824MR, 260920MR, 262243MR1, 262289MR1, 262303MR1, 262363MR1, 262395MR1, 262542MR1, 262544MR1, 262656MR1, 262697MR1, 262785MR1, 262891MR1, 2647, 267985MR, 269341MR3T, 269342MR3T, 269342MR3T2, 269556MR, 269945MR, 269979VOY, 269DVMR, 270251JPMR, 270441LMR, 270444LMR1, 270527MMR, 270688MR2, 270692MRHDE, 270793HDE, 270798HDMR, 270825MR1, 2709263HD, 270965MR1, 272639MR, 276228MR, 276236MR450, 276596450W, 276666MR450W, 281207MR, 281242MR, 281274MR2, 281312MHSHMR, 281333MR1, 281338MR2, 281341MR1, 281348450WMR, 281364HDMR, 281364MR2, 281367MR1, 281420HSMR1, 281440KSFMR, 281477MR2, 281558MR1, 281579KRMR2, 281588MR1, 281637MR1, 281758MR355, 281837MR1, 281840SIGNA, 281879MR, 281880KSFMR1, 281943MR450, 281955MR, 281997MR1, 281AVSMR1, 281BAY450MR1, 281HMI750W, 281HORMR1, 281KELSEYMR1, 281NWARTIST, 281OAKMR1, 281SMCMR1, 281WLMR1, 28859THMR, 3000158, 3003710, 3003856, 3005097, 3008010, 3011062, 3012383, 301279MR3, 301279MR4, 301295MR3T2, 301295MR4, 301459MR, 3014643TMR, 301464MR, 301496MR3T4, 301496MR3T6MR, 301496PETMR, 301548MR, 301570MR, 301609MR, 301637MR, 3016508, 301677MR, 3016808, 301698MR1, 301723MR450W, 301759MR, 301782MR, 301868MR1, 302430MR, 302430MR750W, 302575MR, 302623MR, 302629MR, 302655MR1, 302733MR3T, 302734MR, 302744MR, 302744MR750, 302993MR, 302999MR, 303269MR, 303278MR, 303320MR2, 303338MR1, 303340MR, 303341MR, 303355MR, 303365MR, 303416MR, 303426MR, 303427MR2, 303427MRW, 303433MR, 303436MR, 303444MR, 303446MR, 303451MR, 303466MR, 303467MR, 3034682202MR, 303492MR, 303493MR, 303498MR1, 303577DVMR2, 303604MR2, 303633MR, 303651MR, 303662MR, 303673MR, 303678MR, 303689MR, 303695MR, 303699MR2, 303730MR, 303741TMR, 303761MR, 303762MR, 303789MR, 303794MR, 303837MR1, 303839MR1, 303861KFMR2, 303866MR, 303870MR, 3038998MR, 303933MR1, 303964MR, 303SKYMR3, 303SMIMR1, 304255MR1, 304255VMR, 304255VMR2, 304256MR2, 304269MRI, 304293MR3T, 304347MR1, 304367MR450W, 304429MR1, 304526CMR2, 304526SMR1, 304528MR1, 304636MR, 304647GMR, 304766MR1, 304831MR, 304831MR1, 305223MR2, 305223MR3, 305243MR1, 305256MR1, 305261MR1, 305264MR1, 305275MR1, 305295MR1, 305421MR1, 305445MR1, 3055140, 305592MR1, 305642MR1, 305665MR450W, 305667MR1, 305682MR1, 305696MR450W, 305820MR1, 305823MR3, 305825MR1, 305828MR1, 305835MR450W, 305854MR1, 305933MR1, 305CMISOUTH, 305CVMSMR1, 307352MR, 307382FRONTMR, 307382MR2, 307578MR, 307634MR, 307674SOMR, 307733MR, 307745MR1, 307789MR, 307BHBBJ3T, 307FRMIMR, 307FRMIMR2, 307PBJCASMR, 307PBJCHEYMR, 307SUMMITMR, 307SWRMR, 308255MR, 308284MR, 308398HDMR, 308432MR, 308995PMR, 308PVMR, 309353PMR, 309661CINFMR1, 3096653TMR, 309672MR450W, 309683MNMR750, 309691MR, 309691P450W, 310257MR1, 310264MR, 310289MR, 310301MR, 310316MR, 310358MR3, 310358VMR, 310478MR2, 310532MR, 310623MR, 3106573TMR, 310671MR, 310740MR, 310806MR2, 310832MR, 3109, 310943MR, 312227750WMR, 312355CVMR, 312355DVMR, 312355MR9TC, 312471MR, 312702KMR3T, 312702MR3T, 312702MR450, 312770SMR, 312942CMR2, 312947MR, 312996MR3T, 312CCHMR2, 313294MOB2, 313294MR, 313593MR3T, 3137453TMR, 313745ART1, 313745DMCMR, 313791MRM, 313916PREMIER, 313916PREMIER2, 314251MMR2, 314344CDIMR1, 314432CDIMRF, 314434LWMR1, 314467SJSMR1, 314525MCCMR, 314525SAMR, 314543SAMR1, 314567BRMR, 314577CGMR3T, 314644IMR1, 314743AMR, 314768MR, 314849MEDFMR, 314EMERSONMR, 315338HDX, 315393HDMR, 315425VAMR, 315452NORTH, 315470MR, 315792MR, 315823MR, 315922MR, 315CNYCLAYMR, 315LCGHMR, 315MDR2POB, 315MDRBRIT, 315MDREAST_DEL, 315MDRRADISSON, 315MDRSTJOES, 315ORTHOEASTMR, 315SOS450W, 315SOSNORTH, 315UBJARCH, 315UBJART, 316262MR450, 316268MR, 316268TWIN3, 316688WMR, 316689MR, 316689WCMR1, 316858MR450, 317204MR1, 317228MR1, 3173383T1, 317344MR1, 317415MR2, 317582MR2, 317745MR3, 317834MR1, 317851MR1, 317865HDE, 317865MR3, 317865MR360, 317874MR1, 317887MR2, 317887MR3, 317888MR1, 317899MR, 318214MR, 318254MR, 318329MR, 318330MR, 318336MR1, 318371MR, 318386MR, 318425HFO, 318442CMR1, 318443MR2, 318448MR, 318675LMR2, 318681CBMR, 318769MR, 318798450W, 318798MR, 318812HDMR, 318869MR, 319268MR, 319335MR2, 319768GRMR1, 320255VOY, 320257MR1, 320523MR1, 320589MR, 320693MR, 321207MR, 321434MR2, 321CLMRVOY, 321FCMR1, 321MR3T2, 321MR3T3, 321WLMR, 321WMC450W, 323268MR2, 323294VMR, 323374MR, 323441MR1, 323442MR1, 323442MR3, 323648MR, 323669MR, 323724MRPRO, 323932MR1, 325307HPMR, 325574MRV, 325670ICMR, 330263450W, 330334MR, 330342MR, 330344MR750W, 330363450W, 330363MR, 330385MR, 330489MR450W, 330535MR2, 330729HDE, 330729MR, 330746MR, 330757MR, 330830MR, 330834GSMR, 330841MR, 330896MR, 330945MR, 331216MR, 333NFMR2, 334222MR, 334244MR, 334273CIC750W, 334277SIS, 334286BMR2, 334287MR, 334347MR, 334358MR2, 334418450W, 334636MR, 334676450W, 334684MOB1, 334699MR, 334732HDMR, 334732MR, 334826450W, 336397P3T, 336503PMMR, 336625DVMR, 336719MR, 336719MRI, 336760DVMR, 336765MR1, 336832MR1, 336832WMR1, 337237MR1, 337261MR1, 337289MR1, 337363MR450, 337365MR1, 337367MR1, 337521MR1, 337531MR, 337560MR1, 337580MR1, 337593MR2, 337898MR1, 337943MR1, 337981MR1, 352237MR1, 352265MR1, 352333NFMR1, 352336MR1, 352344MR2, 352344MR3, 352401MR, 352521MR1, 352564MR, 352596MR, 352597MR1, 352620MR1, 352684MR, 352746MR, 352867MR2, 352871MR, 352VAMR1, 352VAMR3T, 352WATOUT, 3591, 3600, 360236MR1, 360254NMR1, 360397MR2, 360425MR1, 360449MR1, 360487MR2, 360571MR1, 360577MR1, 360582450WPA, 360582MR2, 360636MR1, 360692WSMR, 360696MR1, 360744HM450MR, 360754MRCM, 360786ONIMR, 361275PIONMR, 361570LXMR, 361572CICMR, 361887CMR, 361ORTHOMR, 370MR, 386362MR, 386385MR1, 386860LXMR, 386917MR, 386AIMR, 386FHDMR, 386FHPCMR3T, 386FMR3T, 386FNSBMR3T, 386HPOMR, 401331MR, 401333RIMR, 401348MR1, 401444MR3T, 402219MR3T, 402228MR, 402336MR, 402362DVMR, 402375HDE, 402384MNMR, 402463MR, 402484MR, 402572MR, 402778OWMR1, 402873NEBMR, 402879MR, 402926NHI, 402VCAMR, 403152, 404256AMR1, 404256OMR, 404296MR, 404297DOMR, 404297UMR, 404299AMR, 404325WMR, 4043503TMR, 404351MR, 404352PNC, 404355POCMR, 404605MR, 404605PKMR, 404772NMR3T, 404778MR, 404778MR1, 404778PETMR, 405224GHDE, 405271EMR, 405271OUCMR, 405271PMR1, 405271UMR, 405272SMR, 405273PMR, 405307NHD, 405307NMR, 405340MR, 405350MR, 405359EMR, 405375MMR, 405...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide Distribution: US (nationwide), including Puerto Rico and the U.S. Virgin Islands; and OUS (Foreign) was made to Albania, Algeria, Argentina, Armenia, ASEAN HQ, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Republic of Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Kyrhyzstan, Latvia, Lebanon, Libyan Arabic Jamahiriya, Lithuania, Luxembourg, Macedonia, Madagascar, Malawi, Malaysia, Mali, Malta, Mauritania, Mexico, Republic of Moldova, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Nordic-HQ, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zambia, and Zimbabwe.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Apr 27, 2022
Recall initiation date: Mar 4, 2022
Center classification date: Apr 21, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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