Recalls affecting Hawaii

FDA has not published a risk classification for this recall yet.

Recall #:

98232

Lot/product code:

Model/Catalog Number: 81557; UDI-DI: 05414470815579; Lot Numbers: D5C6094U, D5C6125U;

Recalling firm:

Fujirebio Diagnostics, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98232

Lot/product code:

Model/Catalog Number: 81559; UDI-DI: 05414470815593; Lot Number: T8B6116U;

Recalling firm:

Fujirebio Diagnostics, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98232

Lot/product code:

Model/Catalog Number: CL0073; UDI-DI: 00869164000086; Distribution for Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio ("Ratio") is related to the "Ratio" Instructions for Use (IFU). Therefore, each consignee has 1 "Ratio" in which they purchase the component kits for.

Recalling firm:

Fujirebio Diagnostics, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98232

Lot/product code:

Model/Catalog Number: 81558; UDI-DI: 05414470815586; Lot Numbers: D6C6092U, D6C6092U1, D6C6123U;

Recalling firm:

Fujirebio Diagnostics, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98232

Lot/product code:

Model/Catalog Number: 235447; UDI-DI: 04987270235447; Lot Numbers: C5C6022U, C5C6045U;

Recalling firm:

Fujirebio Diagnostics, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98232

Lot/product code:

Model/Catalog Number: 81550; UDI-DI: 05414470815500; Lot Numbers: D4C6028U, D4C6029U, D4C6051U, D4C6052U;

Recalling firm:

Fujirebio Diagnostics, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98823

Lot/product code:

UDI-DI: 00842271175373, Lot: YBDGLD

Recalling firm:

Sagemax Bioceramics, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98260

Lot/product code:

PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

Recalling firm:

REPLIGEN CORPORATION

FDA has not published a risk classification for this recall yet.

Recall #:

98133

Lot/product code:

UDI/DI Not applicable: All serial numbers in distribution

Recalling firm:

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA has not published a risk classification for this recall yet.

Recall #:

98133

Lot/product code:

UDI/DI Not applicable: All serial numbers in distribution

Recalling firm:

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA has not published a risk classification for this recall yet.

Recall #:

98133

Lot/product code:

UDI/DI Not applicable: All serial numbers in distribution

Recalling firm:

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA has not published a risk classification for this recall yet.

Recall #:

98199

Lot/product code:

Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895

Recalling firm:

Mazor Robotics Ltd

FDA has not published a risk classification for this recall yet.

Recall #:

98133

Lot/product code:

UDI/DI Not applicable: All serial numbers in distribution

Recalling firm:

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA has not published a risk classification for this recall yet.

Recall #:

98116

Lot/product code:

MOSAIQ v 3.10.200, and 3.1.1.0 up to and including v 3.2.3.1 with Particle Base. Software Versions: 3.10.200, 3.1.1.0, 3.1.2.0, 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3, 3.1.3.4, 3.2.0.0, 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4, 3.2.2.0, 3.2.2.1, 3.2.3.0, 3.2.3.1 UDI-DI: 07340201500026, 07340201500071

Recalling firm:

Elekta, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98817

Lot/product code:

Serial Numbers: 2-03409NB4DT 2-03560NB4DT 2-03798NB4DT 2-03472NB4DT 2-03315NB4DT 2-03726NB4DT 2-03396NB4DT 2-03320NB4DT 2-03447NB4DT 2-03564NB4DT 2-03516NB4DT 2-03467NB4DT 2-03292NB4DT 2-03371NB4DT 2-03433NB4DT 2-03446NB4DT 2-03343NB4DT 2-03400NB4DT 2-03342NB4DT 2-03547NB4DT 2-03449NB4DT 2-03685NB4DT 2-03574NB4DT 2-03392NB4DT 2-03345NB4DT 2-03431NB4DT 2-03608NB4DT 2-03530NB4DT 2-03501NB4DT 2-03362NB4DT 2-03603NB4DT 2-03713NB4DT 2-03508NB4DT 2-03341NB4DT 2-03418NB4DT 2-03721NB4DT 2-03662NB4DT 2-03679NB4DT 2-03591NB4DT 2-03319NB4DT 2-03411NB4DT 2-03505NB4DT 2-03335NB4DT 2-03585NB4DT 2-03556NB4DT 2-03355NB4DT 2-03664NB4DT 2-03515NB4DT 2-03424NB4DT 2-03470NB4DT 2-03386NB4DT 2-03455NB4DT 2-03401NB4DT 2-03391NB4DT 2-03578NB4DT 2-03388NB4DT 2-03632NB4DT 2-03615NB4DT 2-03434NB4DT 2-03454NB4DT 2-03387NB4DT 2-03390NB4DT 2-03569NB4DT 2-03541NB4DT 2-03509NB4DT 2-03789NB4DT 2-03804NB4DT 2-03439NB4DT 2-03367NB4DT 2-03442NB4DT 2-03750NB4DT 2-03349NB4DT 2-03510NB4DT 2-03538NB4DT 2-03559NB4DT 2-03539NB4DT 2-03491NB4DT 2-03502NB4DT 2-03629NB4DT 2-03383NB4DT 2-03496NB4DT 2-03619NB4DT 2-03511NB4DT 2-03670NB4DT 2-03565NB4DT 2-03581NB4DT 2-03479NB4DT 2-03348NB4DT 2-03534NB4DT 2-03484NB4DT 2-03802NB4DT 2-03504NB4DT 2-03457NB4DT 2-03417NB4DT 2-03482NB4DT 2-03318NB4DT 2-03503NB4DT 2-03518NB4DT 2-03350NB4DT 2-03686NB4DT 2-03317NB4DT 2-03687NB4DT 2-03507NB4DT 2-03663NB4DT 2-03658NB4DT 2-03330NB4DT 2-03489NB4DT 2-03451NB4DT 2-03486NB4DT 2-03465NB4DT 2-03346NB4DT 2-03598NB4DT 2-03377NB4DT 2-03414NB4DT 2-03422NB4DT 2-03531NB4DT 2-03329NB4DT 2-03579NB4DT 2-03817NB4DT 2-03613NB4DT 2-03322NB4DT 2-03570NB4DT 2-03397NB4DT 2-03326NB4DT 2-03347NB4DT 2-03469NB4DT 2-03483NB4DT 2-03359NB4DT 2-03344NB4DT 2-03436NB4DT 2-03711NB4DT 2-03437NB4DT 2-03459NB4DT 2-03384NB4DT 2-03389NB4DT 2-03592NB4DT 2-03432NB4DT 2-03823NB4DT 2-03616NB4DT 2-03498NB4DT 2-03512NB4DT 2-03809NB4DT 2-03647NB4DT 2-03606NB4DT 2-03722NB4DT 2-03818NB4DT 2-03589NB4DT 2-03356NB4DT 2-03583NB4DT 2-03799NB4DT 2-03487NB4DT 2-03398NB4DT 2-03775NB4DT 2-03427NB4DT 2-03533NB4DT 2-03676NB4DT 2-03468NB4DT 2-03684NB4DT 2-03413NB4DT 2-03716NB4DT 2-03374NB4DT 2-03430NB4DT 2-03473NB4DT 2-03575NB4DT 2-03339NB4DT 2-03666NB4DT 2-03323NB4DT 2-03471NB4DT 2-03334NB4DT 2-03310NB4DT 2-03631NB4DT 2-03405NB4DT 2-03720NB4DT 2-03372NB4DT 2-03463NB4DT 2-03353NB4DT 2-03563NB4DT 2-03419NB4DT 2-03725NB4DT 2-03621NB4DT 2-03336NB4DT 2-03312NB4DT 2-03806NB4DT 2-03572NB4DT 2-03597NB4DT 2-03370NB4DT 2-03435NB4DT 2-03354NB4DT 2-03555NB4DT 2-03440NB4DT 2-03376NB4DT 2-03610NB4DT 2-03653NB4DT 2-03749NB4DT 2-03380NB4DT 2-03558NB4DT 2-03462NB4DT 2-03313NB4DT 2-03517NB4DT 2-03790NB4DT 2-03513NB4DT 2-03602NB4DT 2-03683NB4DT 2-03561NB4DT 2-03514NB4DT 2-03604NB4DT 2-03445NB4DT 2-03423NB4DT 2-03338NB4DT 2-03375NB4DT 2-03361NB4DT 2-03543NB4DT 2-03492NB4DT 2-03801NB4DT 2-03497NB4DT 2-03601NB4DT 2-03824NB4DT 2-03477NB4DT 2-03545NB4DT 2-03813NB4DT 2-03557NB4DT 2-03426NB4DT 2-03428NB4DT 2-03394NB4DT 2-03645NB4DT 2-03842NB4DT 2-03528NB4DT 2-03321NB4DT 2-03478NB4DT 2-03438NB4DT 2-03369NB4DT 2-03661NB4DT 2-03682NB4DT 2-03412NB4DT 2-03351NB4DT 2-03673NB4DT 2-03453NB4DT 2-03605NB4DT 2-03461NB4DT 2-03495NB4DT 2-03582NB4DT 2-03540NB4DT 2-03594NB4DT 2-03612NB4DT 2-03810NB4DT 2-03364NB4DT 2-03609NB4DT 2-03672NB4DT 2-03529NB4DT 2-03379NB4DT 2-03554NB4DT 2-03490NB4DT 2-03407NB4DT 2-03586NB4DT 2-03600NB4DT 2-03618NB4DT 2-03421NB4DT 2-03659NB4DT 2-03671NB4DT 2-03448NB4DT 2-03607NB4DT 2-03402NB4DT 2-03485NB4DT 2-03480NB4DT 2-03420NB4DT 2-03328NB4DT 2-03408NB4DT 2-03481NB4DT 2-03625NB4DT 2-03331NB4DT 2-03614NB4DT 2-03646NB4DT 2-03668NB4DT 2-03800NB4DT 2-03499NB4DT 2-03753NB4DT 2-03520NB4DT 2-03464NB4DT 2-03316NB4DT 2-03580NB4DT 2-03675NB4DT 2-03665NB4DT 2-03546NB4DT 2-03590NB4DT 2-03544NB4DT 2-03415NB4DT 2-03719NB4DT 2-03456NB4DT 2-03532NB4DT 2-03385NB4DT 2-03452NB4DT 2-03593NB4DT 2-03366NB4DT 2-03759NB4DT 2-03506NB4DT 2-03425NB4DT 2-03660NB4DT 2-03360NB4DT 2-03519NB4DT 2-03688NB4DT 2-03537NB4DT 2-03429NB4DT 2-03406NB4DT 2-03340NB4DT 2-03311NB4DT 2-03562NB4DT 2-03474NB4DT 2-03655NB4DT 2-03466NB4DT 2-03595NB4DT 2-03476NB4DT 2-03403NB4DT 2-03752NB4DT 2-03332NB4DT 2-03314NB4DT 2-03309NB4DT 2-03678NB4DT 2-03410NB4DT 2-03460NB4DT 2-03717NB4DT 2-03521NB4DT 2-03674NB4DT 2-03363NB4DT 2-03667NB4DT 2-03475NB4DT 2-03724NB4DT 2-03493NB4DT 2-03617NB4DT 2-03680NB4DT 2-03494NB4DT 2-03450NB4DT 2-03754NB4DT 2-03378NB4DT 2-03712NB4DT 2-03840NB4DT 2-03441NB4DT 2-03416NB4DT 2-03393NB4DT 2-03577NB4DT 2-03751NB4DT 2-03681NB4DT 2-03368NB4DT 2-03333NB4DT 2-03640NB4DT 2-03373NB4DT 2-03358NB4DT 2-03500NB4DT 2-03596NB4DT 2-03811NB4DT 2-03308NB4DT 2-03669NB4DT 2-03337NB4DT 2-03381NB4DT 2-03352NB4DT 2-03488NB4DT 2-03382NB4DT 2-03443NB4DT 2-03357NB4DT 2-03444NB4DT 2-03542NB4DT 2-03599NB4DT 2-03404NB4DT 2-03395NB4DT 2-03365NB4DT 2-03399NB4DT 2-03576NB4DT 2-03458NB4DT 2-03611NB4DT

Recalling firm:

Daavlin Distributing Company

FDA has not published a risk classification for this recall yet.

Recall #:

98078

Lot/product code:

Lot Code: UDI-DI: 04260102136243; 04260102136274

Recalling firm:

Heraeus Medical GmbH (Dental Division)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0240-2026

Lot/product code:

Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.

Recalling firm:

SUN PHARMA /TARO

FDA has not published a risk classification for this recall yet.

Recall #:

98383

Lot/product code:

Lot Code: 420189, Double Fenestrated Grasper GTIN: 00886874111581 FDA Medical Device Listing Number: D088920 Material Number: 420189-07 Batch / System Numbers: M10120911 SH1182 M10130103 SH1182 M10130116 SH1182 M10130124 SH1182 M10130422 SH1182 M10130731 SH1182 M10130918 SH1182 M10110112 SG704 M10110202 SG704 M10110318 SG704 M10111028 SG704 M20111221 SG704 M10120220 SG704 M10120419 SG704 M10130110 SG704 M10130422 SG704 M10130726 SG704 M10130802 SG704 M10130802 SH0547 M10130918 SH0547 M10110808 SH0059 M10111027 SH0059 M10111104 SH0059 M10121123 SH0059 M10121213 SH0059 M10130103 SH0059 M10130815 SH1557 M10130625 SH1390 M10130731 SH1390 M10130802 SH1390 M10130603 USG721 M10120911 SH0825 M10120727 SH1378 M10121026 SH1378 M10121105 SH1378 M10130121 SH1378 M10130207 SH1378 M10130218 SH1378 M10130322 SH1378 M10130315 SH1378 M10130422 SH1378 M10130603 SH1378 M10130625 SH1378 M10130726 SH1378 M10131010 SH1378 M10110309 SH0729 M10110415 SH0729 M10110621 SH0729 M10110812 SH0729 M10121009 SH0729 M10130103 SH0729 M10130124 SH1622 M10120125 SH1076 M10121113 SH1076 M10130426 SH1604 M10120719 SH1385 M10120727 SH1385 M10120822 SH1385 M10120829 SH2144 M10111104 SH0761 M10120327 SH1276 M10120522 SH1276 M10121026 SH1276 M10130514 SH1276 M10130426 USG518 M10130829 USG518 Material Number: 420189-09 Batch / System Numbers: M10131104 SH1182 M10140228 SH1182 M10140414 SH1182 N10140508 SH1182 N10140619 SH1182 N10140703 SH1182 N10140812 SH1182 N10140902 SH1182 N10141204 SH1182 N10150430 SH1182 N10150814 SH1182 N10150916 SH1182 N10151106 SH1182 N10151119 SH1182 N10160429 SH1182 N10160520 SH1182 N10150825 SH1182 N10160617 SH1182 N10160914 SH1182 N10161012 SH1182 N10161222 SH1182 N10160908 SH1182 N10180105 SH1182 N10140521 SG704 N10140801 SG704 N10141017 SG704 N10150309 SG704 N10150526 SG704 N10150805 SG704 N10160106 SG704 N10160429 SG704 N10160425 SG704 N10160901 SG704 N10170330 SG704 N10171116 SG704 N10171121 SG704 N10150219 SH0547 N10160408 SH0547 M10140324 SH0059 N10140902 SH0059 N10141121 SH0059 N10150227 SH0059 N10150409 SH0059 N10150626 SH0059 N10160901 SH0059 N10160914 SH0059 N10161012 SH0059 N10161122 SH0059 N10171212 SH0059 N10150416 SH1557 N10150727 SH1557 N10160229 SH1557 N10151201 SH1557 N10160520 SH1557 N10160817 SH1557 N10161012 SH1557 N10161122 SH1557 N10170130 SH1557 N10170210 SH1557 N10160825 SH1557 N10170515 SH1557 N10170815 SH1557 N10171116 SH1557 N10171121 SH1557 N10180105 SH1557 M10131108 SH1390 N10141017 SH1390 N10170825 SH1368 N10160525 USG721 N10160808 USG721 M10140327 SH2186 N10140902 SH0825 N10141027 SH0825 N10160114 SH0825 N10161027 SH0825 N10171116 SH0825 M10131025 SH1378 M10131104 SH1378 M10140214 SH1378 M10140324 SH1378 N10140508 SH1378 N10140902 SH1378 N10141030 SH1378 N10141204 SH1378 N10160203 SH1378 N10170330 SH1378 M10140325 SH0729 N10140711 SH0729 N10150122 SH0729 N10150910 SH0729 N10151217 SH0729 N10160509 SH0729 N10160216 SH0035 N10170609 SH0035 M10140327 SH2125 N10140603 SH2125 N10160718 SH2125 N10161209 SH2125 N10171019 SH1604 N10171220 SH1604 N10170531 SH1279 N10170609 SH1279 N10170628 SH1279 N10140711 SH2144 N10150129 SH2144 N10150526 SH2144 N10150727 SH2144 N10151119 SH2144 N10160914 SH2144 N10161222 SH2144 N10171204 SH2144 M10140414 SH1276 N10140603 SH1276 N10150129 USG518 Material Number: 420189-10 Batch / System Numbers: N10180409 SH1182 N10180702 SH1182 N10180509 SG704 N10180223 SH1557 N10180712 SH1557 N12180123 SH0825 N10180409 SH1279 Material Number: 420189-11 Batch / System Numbers: N10190128 SH1182 N10190206 SH1182 N10180814 SH1557 N10181005 SH1557 N10180802 SH1557 N10180928 SH1557 N10190423 SH1557 N10190902 SH1557 N10180814 SH0825 N10190805 SH0825 N10190306 SH2180 N10190128 SH1604 N10180814 SH2144 Material Number: 420189-12 Batch / System Numbers: N10190715 SH1182 N10190502 SH1182 N10190513 SH1182 N10190513 SH1557 N10190408 SH1557 N10190715 SH1557 N10200217 SH1557 N10200803 SH1557 N10201005 SH1557 N10210419 SH1557 N10210210 SH1557 N10200217 SH1964 N10200720 SH1964 N10200427 SH1964 N10210419 SH1964 N10210308 SH1964 N10210713 SH1964 N10200427 SH1604 N10210104 SH1604 N10190502 SH1385 N10210913 SH2144 K10220925 SH2144 K10231026 SH2144

Recalling firm:

Intuitive Surgical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98078

Lot/product code:

Lot Code: UDI-DI: 04260102136120; 04260102136151

Recalling firm:

Heraeus Medical GmbH (Dental Division)

FDA has not published a risk classification for this recall yet.

Recall #:

98383

Lot/product code:

Lot Code: 420179: Monopolar Curved Scissors (Hot Shears) GTIN: 00886874111505 FDA Medical Device Number: D088920 Material Number: 420179-10 Batch / System Numbers: M10101102 SH0935 M10101201 SH0935 M10101202 SH1279 M10101203 SH0059 M10101204 USG294 M10101206 USG294 M10101206 SH1378 M10101214 USG022 M10101214 SH0035 M10101214 SH0495 M10110104 SH1279 M10110111 SH1378 M10110112 USG294 M10110113 SH0075 M10110121 SG704 M10110121 SH1279 M10110124 SH0495 M10110126 USG721 M10110126 SH1391 M10110127 USG721 M10110127 SH1279 M10110127 SH2144 M10110202 USG294 M10110202 SH0495 M10110203 SH2144 M10110208 SG704 M10110210 SH1378 M10110216 SH1368 M10110216 USG294 M10110216 SH1391 M10110217 SH0495 M10110217 SH1279 M10110222 SH1279 M10110228 SH0547 M10110228 USG721 M10110228 USG022 M10110228 SH1378 M10110228 SH1279 M10110301 SH1279 M10110303 SH0495 M10110304 USG294 M10110304 SH0729 M10110304 SH0761 M10110307 USG294 M10110308 USG294 M10110308 SH0035 M10110308 SH0495 M10110308 SH1279 M10110311 USG294 M10110311 SH2144 M10110315 USG294 M10110318 USG294 M10110318 SH0935 M10110318 SH1279 M10110323 USG022 M10110324 SH0059 M10110324 USG022 M10110324 SH0495 M10110328 USG294 M10110328 SH0935 M10110328 SH1279 M10110329 USG294 M10110329 SH0935 M10110331 SH0935 M10110405 SH1378 M10110413 USG294 M10110413 SH1279 M10110414 SG704 M10110414 SH0495 M10110420 SH1279 M10110425 SH0035 M10110426 SH0059 M10110428 USG022 M10110429 SG2026 M10110429 SH0035 M10110504 USG294 M10110512 USG294 M10110512 USG022 M10110512 SH2144 M10110517 USG294 M10110517 SH0495 M10110518 SH0035 M10110524 USG294 M10110524 SH1279 M10110525 USG294 M10110526 USG294 M10110526 SH1378 M10110602 SH1279 M10110603 SH1378 M10110614 SH1279 M10110616 SH1368 M10110617 SH1182 M10110617 SH0495 M10110621 SH2144 M10110622 SH0935 M10110623 SH0729 M10110624 SH1378 M10110629 USG294 M10110630 SH1279 M10110630 SH2144 M10110701 SH1378 M10110705 SH0035 M10110711 USG294 M10110712 SH1378 M10110712 SH0495 M10110715 SH1279 M10110715 SH2144 M10110718 SH0761 M10110721 SH0935 M10110728 SH0729 M10110728 SH0761 M10110729 USG721 M10110801 SH1279 M10110802 SH0935 M10110803 USG294 M10110803 USG022 M10110803 SH2144 M10110805 SG704 M10110805 SH0495 M10110808 SH0035 M10110809 USG721 M10110810 SH1279 M10110811 USG022 M10110811 SH0729 M10110812 USG721 M10110812 SH0729 M10110815 SH0935 M10110815 SH1279 M10110816 SG704 M10110816 USG721 M10110816 SH0729 M10110819 USG294 M10110822 SG704 M10110822 USG294 M10110823 SH0729 M10110824 SH0059 M10110824 SH0729 M10110824 SH0495 M10110825 USG721 M10110826 USG721 M10110829 SH1279 M10110830 USG022 M10110902 SG704 M10110902 SH1279 M10110902 SH0761 M10110906 USG022 M10110908 USG721 M10110908 SH1378 M10110908 SH1279 M10110909 SH0495 M10110913 USG721 M10110922 SH2144 M10110923 USG294 M10110923 SH0729 M10110930 SH0935 M10110930 SH0495 M10111003 SG704 M10111004 USG294 M10111005 USG294 M10111006 SH0729 M10111007 SH1368 M10111007 SH0035 M10111007 SH2144 M10111010 SH0935 M10111011 SH0495 M10111011 SH1279 M10111013 SH1378 M10111015 USG022 M10111017 SH1015 M10111018 SH1368 M10111018 SH1279 M10111019 USG294 M10111020 SH0547 M10111020 SH1279 M10111021 USG022 M10111027 SG704 M10111027 SH1378 M10111028 SH0059 M10111028 USG294 M10111028 SH2144 M10111031 SH1015 M10111104 SH1182 M10111107 SH0059 M10111107 SH0729 M10111107 SH0761 M10111108 SH1279 M10111108 SH2144 M10111109 SH0495 M10111111 SH0935 M10111114 USG294 M10111114 SH0729 M10111114 SH1279 M10111115 SG704 M10111115 USG294 M10111115 USG022 M10111116 SH0825 M10111117 SH0729 M10111117 SH1391 M10111117 SH0761 M10111118 SH0935 M10111122 SH0495 M10111122 SH0761 M10111123 SH1390 M10111123 USG294 M10111123 SH0035 M10111124 USG294 M10111129 SH0935 M10111130 SH1378 M10111201 SH1368 M10111202 USG294 M10111202 SH0729 M10111208 USG294 M10111208 SH1279 M10111212 SH1378 M10111213 SG704 M10111213 SH1279 M10111214 USG294 M10111214 SH0729 M10111214 SH1015 M10111216 SH0495 M10111221 USG294 M10111221 SH1378 M10120104 SH1182 M10120104 USG022 M10120104 SH1279 M10120105 USG294 M10120109 USG022 M10120111 SH2144 M10120112 USG721 M10120113 SH0495 M10120117 SH0495 M10120117 SH1279 M10120127 USG294 M10120130 SG704 M10120130 SH1279 M10120131 SH0729 M10120201 SH1390 M10120201 SH0729 M10120203 SH0935 M10120208 SH0729 M10120208 SH1279 M10120208 SH2144 M10120209 SH1378 M10120213 SH0495 M10120214 SH1279 M10120216 SG704 M10120216 SH0495 M10120217 SH1182 M10120217 SH0761 M10120221 SH0729 M10120222 SH1391 M10120224 SH1390 M10120224 USG294 M10120224 SH0729 M10120228 SH1279 M10120301 SH1015 M10120305 SH1279 M10120308 SH0729 M10120309 SH0935 M10120312 USG022 M10120312 SH0935 M10120312 SH1015 M10120313 SH0825 M10120315 SH1279 M10120315 SH2144 M10120316 SH1390 M10120316 SH0729 M10120316 SH1279 M10120317 SH1276 M10120320 SG704 M10120320 SH1368 M10120320 SH1378 M10120320 SH0729 M10120321 SG2026 M10120326 SH1076 M10120327 SH0935 M10120330 SH0059 M10120330 USG294 M10120402 SH1279 M10120403 SH0729 M10120403 SH0495 M10120404 SH1279 M10120409 SH2144 M10120411 SG2026 M10120411 SH2144 M10… (truncated, 53194 characters total — see the official FDA record for the full value)

Recalling firm:

Intuitive Surgical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98383

Lot/product code:

Lot Code: 420278: Grasping Retractor GTIN: 00886874111772 FDA Medical Device Listing Number: D088920 Material Number: 420278-04 Batch / System Numbers: M10110613 SH1182 M10120127 SH1182 M10120217 SH1182 M10120829 SH1182 M10130103 SH1182 M10130114 SH1182 M11130404 SH1182 M10130527 SH1182 M10130606 SH1182 M10130909 SH1182 M10130925 SH1182 S10101229 SG704 S10110105 SG704 M10121214 SH0547 M10110118 SH0059 M10110613 SH0059 S10110819 SH0059 M10121122 SH0059 M10121214 SH0059 M10130114 SH0059 M10130220 SH0059 M10130319 SH0059 M11130404 SH0059 M10120912 SH1390 M10130730 USG721 M10130909 USG721 M10110307 SH0729 M10130214 SH0729 M11130404 SH0729 M10130617 SH0729 M10130628 SH0729 M10120127 SH1076 M10130307 SH1279 M10111028 SH0761 Material Number: 420278-06 Batch / System Numbers: M10140115 SH1182 N10140725 SH1182 N10140923 SH1182 N10150324 SH1182 N10150417 SH1182 N10150721 SH1182 N10150608 SH1182 N10150820 SH1182 N10151113 SH1182 N10151214 SH1182 N10151029 SH1182 N10160304 SH1182 N10151201 SH1182 N10141205 SH1182 N10160921 SH1182 N10161123 SH1182 N10170516 SH1182 N10170601 SH1182 N10170921 SH1182 N10171213 SH1182 N10171226 SH1182 N10180417 SH1182 N10140815 SG704 N10150210 SG704 N10150608 SG704 N10160203 SG704 N10170117 SG704 N10170921 SG704 N10170822 SG704 N10171002 SG704 N10171226 SG704 M10140306 SH0059 N10141205 SH0059 N10150605 SH0059 N10170213 SH0059 N10171213 SH0059 N10171117 SH1964 N10180417 SH1964 N10170310 USG294 M10140306 USG721 M10140319 USG721 N10170412 USG721 N10180117 USG721 N10150224 SH1378 N10160203 SH1378 M10140306 SH0729 N10140828 SH0729 N10150330 SH0729 N10150319 SH0729 N10150525 SH0729 N10151020 SH0729 N10160503 SH0729 N10160524 SH0729 N10180417 SH0729 N10141001 SH1076 N10141030 SH1076 N10151211 SH1604 N10160524 SH1604 N10160801 SH1604 N10160921 SH1604 N10171226 SH1604 N10160921 SH1385 N10161010 SH1385 N10161114 SH1385 N10171117 SH1385 Material Number: 420278-07 Batch / System Numbers: N10181219 SH1182 N10180906 SH1182 N10190423 SH1182 N10181114 SH1182 N10180906 SG704 N10180910 USG721 N10181114 SH1604 Material Number: 420278-09 Batch / System Numbers: N10190826 SH1182 N10190515 SH1182 N10190909 SH1182 N10190902 SH1964 N10190826 SH1964 N10190515 SH1964 N10190909 SH1964 N10190826 USG721 N10190902 SH1604

Recalling firm:

Intuitive Surgical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98383

Lot/product code:

Lot Code: 420194, Mega Needle Driver GTIN: 00886874111611 FDA Medical Device Listing Number: D088920 Material Number: 420194-08 Batch / System Numbers: M10120201 SH1182 M20120412 SH1182 M10130121 SH1570 M10130306 SH1570 M10110602 SH0547 M10110627 SH0547 M10121129 SH0059 M10121214 SH0059 M10130429 SH0059 M10130521 SH0059 M10121105 SH1557 M10130517 SH1837 M10121109 SH1390 M10130508 SH1390 M10131004 SH1390 M10130306 USG689 M10130412 USG689 M10110302 SH1368 M10110614 SH1368 M10110620 SH1368 M10110817 SH1368 M10120705 SH1368 M10121022 SH1368 M10130429 SH1368 M10130509 SH1368 M10130722 SH1368 M10110131 USG294 M10110511 USG294 M10110616 USG294 M10110811 USG294 M10111003 USG294 M20111103 USG294 M10111206 USG294 M20120103 USG294 M10120130 USG294 M10120305 USG294 M10120425 USG294 M10120713 USG294 M10121004 USG294 M10121017 USG294 M10121022 USG294 M10121105 USG294 M10121107 USG294 M10121206 USG294 M10121207 USG294 M10130108 USG294 M10130112 USG294 M10130201 USG294 M10130213 USG294 M10130215 USG294 M10130529 USG294 M11130608 USG294 M10130718 USG294 M10130829 USG294 M10120321 SG2026 M10120605 SG2026 M10111114 SH0825 M10110330 SH0935 M10110401 SH0935 M10120123 SH0935 M10120313 SH0935 M10120404 SH0935 M10120802 SH0935 M10120919 SH0935 M10121121 SH0935 M10110302 SH0729 M10110503 SH0729 M10110701 SH0729 M10110809 SH0729 M10110817 SH0729 M10110825 SH0729 M10110913 SH0729 M10110923 SH0729 M10111116 SH0729 M20111123 SH0729 M10111201 SH0729 M10120120 SH0729 M10120130 SH0729 M10120210 SH0729 M10120217 SH0729 M10120301 SH0729 M10120412 SH0729 M10120507 SH0729 M10120525 SH0729 M20120530 SH0729 M10120703 SH0729 M10120724 SH0729 M10120803 SH0729 M10120810 SH0729 M10120827 SH0729 M10121025 SH0729 M10130102 SH0729 M10130212 SH0729 M10130213 SH0729 M10130314 SH0729 M10130418 SH0729 M10130517 SH0729 M10130603 SH0729 M10130606 SH0729 M10130617 SH0729 M10130701 SH0729 M10131014 SH0729 N10140430 SH0729 M10101206 SH0035 M10110624 SH0035 M10101206 SH1391 S10110307 SH1391 M10110302 SH1391 M10110701 SH1391 M10120404 SH1391 M10120705 SH1391 M10121010 SH1391 M10130118 SH1391 M10130125 SH1391 M10130515 SH1391 M10130626 SH1391 M10121206 SH1604 M10130308 SH1604 M10101127 SH0495 M10101217 SH0495 M10110131 SH0495 M10110512 SH0495 M10110817 SH0495 M10110901 SH0495 M10111008 SH0495 M20111221 SH0495 M10120217 SH0495 M10120224 SH0495 M10110527 SH0495 M10120727 SH0495 M10121004 SH0495 M10130102 SH0495 M10130213 SH0495 M10130301 SH0495 M10130812 SH0495 M10130924 SH0495 M10111201 SH1015 M10111208 SH1015 M10120217 SH1015 M10120425 SH1015 M10120618 SH1015 M10120713 SH1015 M10120823 SH1015 M10120827 SH1015 M10121022 SH1015 M10130212 SH1015 M10130213 SH1015 M10130828 SH1015 M10120831 SH1385 M10120918 SH1385 M10110412 SH2144 M10110706 SH2144 M10110923 SH2144 M10111008 SH2144 M10111205 SH2144 M20120103 SH2144 M10120210 SH2144 M10120713 SH2144 M10121121 SH2144 M10130325 SH2144 M10130529 SH2144 M10110302 SH0761 M10121129 SH0761 M10130719 SH0761 M10131001 SH0761 M20120322 SH1276 M10120525 SH1276 M10130503 USG518 M10130821 USG518 M10130828 USG518 M10131014 USG518 Material Number: 420194-10 Batch / System Numbers: N10170714 SH1182 N10170817 SH1182 N10171019 SH1182 M10140303 SH1570 N10140805 SH1570 N10150702 SH1570 N10160311 SH1570 N10160421 SH1570 N10161206 SH1570 N10161223 SH1570 N10180227 SG704 M10131121 SH0547 N10140609 SH0547 M10140221 SH0059 M10140307 SH0059 N10140508 SH0059 N10140827 SH0059 N10150320 SH0059 N10160519 SH0059 N10160728 SH0059 N11160907 SH0059 N11161013 SH0059 N10161129 SH0059 N10170419 SH0059 N11170407 SH0059 N10170612 SH0059 N10170705 SH0059 N10180202 SH0059 N10180323 SH0059 N10180321 SH0059 N10180412 SH0059 M10140225 SH1557 N10140605 SH1557 N10140620 SH1557 N10140827 SH1557 N12140929 SH1557 N10150211 SH1557 N10150320 SH1557 N10150528 SH1557 N10150616 SH1557 N10150721 SH1557 N10151209 SH1557 N10160307 SH1557 N10160519 SH1557 N10160509 SH1557 N10160728 SH1557 N10160907 SH1557 N10161031 SH1557 N11170111 SH1557 N11161216 SH1557 N11170427 SH1557 N10170504 SH1557 N10170605 SH1557 N10170914 SH1557 N10171016 SH1557 N10171027 SH1557 N10180118 SH1557 N10180223 SH1557 N10180321 SH1557 N10180427 SH1557 N10150604 SH1964 N10150626 SH1964 N10151207 SH1964 N10151211 SH1964 N10180131 SH1964 N10180223 SH1964 N10180404 SH1964 N10180426 SH1964 N10150814 SH1837 N10160105 SH1837 N10160728 SH1837 N11160901 SH1837 N10150717 SH1390 N10160419 SH1390 M10131211 USG689 N10160519 USG689 M10140515 SH1368 N11141113 SH1368 N10160105 SH1368 N10160718 SH1368 N10170901 SH1368 M10131102 USG294 M10140107 USG294 M10140109 USG294 M10140221 USG294 M10140408 USG294 N10140516 USG294 N10140923 USG294 N10141016 USG294 N10150219 USG294 N10150325 USG294 N10150723 USG294 N10151002 USG294 N10151013 USG294 N10160104 USG294 N10160307 USG294 N10160504 USG294 N11160616 USG294 N11160720 USG294 N10160907 USG294 N11160923 USG294 N10161118 USG294 N10161207 USG294 N10170302 USG294 N10170421 USG294 N10170621 USG294 N10170817 USG294 N10170927 USG294 N10180202 USG294 N10171214 USG294 N10180131 USG294… (truncated, 9643 characters total — see the official FDA record for the full value)

Recalling firm:

Intuitive Surgical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98408

Lot/product code:

Lot Code: 420207: Tenaculum Forceps Instrument GTIN: 00886874111659 FDA Medical Device Number: D088920 Material Number: 420207-06 da Vinci System Numbers: SH1378 SH0935 SH0935 SH0935 USG294 SH0761 SH0729 SH1182 SH1378 USG022 SH1378 SH1368 SH0059 SH1015 SH1182 SH0825 USG294 SH1390 USG022 SH0495 SH0495 SH1076 SH1390 SH1390 SH1390 SH1276 SH1385 USG022 SH0547 SH1385 SH1391 SH2144 SH0059 SH1279 SH0059 SH1390 SH1570 SH0059 SH1391 SG704 SH1570 SH0729 SH1385 SH1378 USG518 SH1385 SH1837 USG294 SH1368 SH1390 SH1385 SH1368 SG2026 SH1557 SH2144 SH1385 USG518 SH1279 USG294 SH1391 Material Number: 420207-07 da Vinci System Numbers: SH1391 SH1385 SH1385 SH1279 SH2125 SH0729 SH1368 USG721 SH1385 SH1997 SH2125 USG294 SH1378 SH1997 SH0035 SG704 SH1385 SH1279 SH1279 SH2125 SH1378 SH1378 SH0495 SH1390 SH1390 SH1385 SH2125 SH1378 SH1385 SH1279 USG721 SH1279 SH1837 USG518 SH1385 SH1378 USG022 SH1378 SH1570 SH1385 SH1385 SH0935 SH0935 SG704 SG704 SH1378 USG022 SH1385 SH1279 USG721 SH1279 USG518 SH1837 SH1279 USG022 SH1385 SH1385 SH1964 SH1385 SH1390 SH1279 SH1964 SH1385 SH1570 USG294 SH1182 SH1279 SH1279 USG022 SH1385 SH0825 USG294 SH0035 SH1276 SH2125 SH1279 RSH0152 USG518 SH1557 SH1837 SH1385 SH1390 SH1279 SH1390 SH1390 USG294 SH1385 SH1279 SH1385 SH1279 SH2125 USG721 SH1837 SH0035 SH1964 SH1837 SH1385 SH1385 SH1279 SH1279 RSH0152 SH1378 SH0495 Material Number: 420207-09 da Vinci System Numbers: RSH0152 SH1378 SH1385 SH1279 USG721 SH1279 SH1378 SH1385 USG721 SH1279 SH1182 SH1390 SH1076 USG721 SH1279 SH1182 SH1385 SH1837 SH1279 SH1837 SH1279 Material Number: 420207-10 da Vinci System Numbers: SH1279 SH1385 SH1390 SH1279 SH1385 SH1182 SH1368 SH1997 SH1279 USG721 SH1822 SH1557 SH1822 SH1964 SH1279 SH0495 SH1390 SH1279 SH1964 USG022 SH1822 SH1378 SH1182 SH1837 SH1279 SH1279 SH1279 SH1279 SH1997 SH1964 SH1964 SH1997 SH0761 SH1279 SH1837 SH1279 SH1279 SH1279 SH1390 SH1279 SH1997

Recalling firm:

Intuitive Surgical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98408

Lot/product code:

Lot Code: 420183, Permanent Cautery Hook GTIN: 00886874111536 FDA Medical Device Listing Number: D088920 Material Numbers: 420183-05 System Numbers: USG294 SH0059 SH0075 SH0059 USG294 Material Number: 420183-06 da Vinci System Numbers: SH1378 SH1378 SH0729 SH1182 USG294 USG294 USG294 SH1015 SH0729 USG294 SH0825 SH1390 SG704 SH0935 SG704 USG022 SH1182 SH0729 SH1390 SH1276 USG294 SH1182 SG704 SH1182 SH1276 SH1076 USG294 SH1015 SH1076 SH1390 USG022 SH2144 SH1182 SH0825 SH1182 SH0547 USG689 SH1385 USG689 USG294 SH1276 SH1076 SH1276 SH0729 SH0059 SH1604 SH0825 USG294 SH1276 SH1378 SH1622 SH1182 SH0059 SH1182 SH1276 SH1276 USG689 USG294 SH1182 SH1276 SH1378 USG518 SH1182 SH1570 SH1276 SH1182 SH0035 SH0825 SH0035 SH1837 SH1276 USG294 SH0059 SH1368 SH1276 SH1570 SH1378 SH1182 SH1378 SH1378 SH0547 SH1276 SH1276 USG518 SH1276 SH1182 SH1015 SH0495 SH1182 SH1390 SH1378 SH1182 SH1276 SH0825 SH1378 SG704 SH1378 SH1276 SH1182 SH0547 SH0935 SH0547 SH1622 SH1182 SH1557 USG294 SH0495 SH1276 SH1557 SH1276 SH1182 SH1391 SH1276 SH1557 SH2186 SH1182 SH1391 SH1182 SH1997 USG294 SH1997 SH2125 SH1276 SH2125 SH1276 SH1182 Material Number: 420183-10 da Vinci System Numbers: SH1182 SH0825 SH1276 SH1182 SH2125 SH1182 USG294 USG294 SH1182 SH1182 SH0547 SH1378 SH0495 SH1182 SH1997 SH1182 SH1276 SH0825 USG518 SH1182 SH1276 SH1276 SH2125 SH0825 SH1182 SH1182 SH1837 SH0935 SH2144 SH0935 SH2125 SH1182 SH1378 SH0935 SH1276 SH1182 SH1622 SH1390 SH2125 SH1557 SH1182 SH1368 SH0935 SH1557 SH1182 SH0495 SH2125 SH0935 SH1182 SH0547 SG704 SH1182 SH1279 SH1557 SH0825 SH2125 SH1076 Material Number: 420183-11 da Vinci System Numbers: SH1390 SH1182 SH2125 SH1557 SG704 SH1015 USG294 SH1015 SH1182 SH1182 USG294 SH1182 SH0935 SH0935 SH1390 SH2125 SH1182 SH1570 SH1182 SH1015 SH2125 USG294 SH1076 SH1378 SH1557 USG689 USG022 SH0035 SH0059 SH1390 SH2125 SH0935 SH1182 SH1015 SH1182 SH1604 SH2125 SH1182 SH1015 SH1182 SH1622 SH1182 SH0059 SH1015 SH1015 SH0935 SH0935 Material Number: 420183-12 da Vinci System Numbers: SH1390 SH2125 SH1182 SH0935 SH1182 SH0059 SH1015 SH0935 SH2125 SH1182 USG518 USG294 SH1182 SH2125 SH1182 SH1570 SH1182 SH1182 SG704 SH2125 SH1182 SH1557 SG704 SH1182 USG294 SH1557 SH2125 USG294 SH1182 SH1557 SH2125 SH0935 SH0825 SH0729 SH1182 SH1557 SH0059 SH1622 SH1182 USG294 SH1378 SH1557 SH2125 SH1076 SH1822 USG294 SH1182 SH1557 SH0825 SH1182 SH0495 SH2125 SH1557 SH2144 SH2125 SG704 SH0059 SH2125 SH1604 Material Number: 420183-14 da Vinci System Numbers: SH1182 SH2125 SH1182 SH2144 SH2144 USG294 SH1622 SH2125 SH1182 SH1182 SH1822 SH2125 USG721 SH0729 SH1822 SG704 SH2125 SH0825 SH1015 SH1182 SH1182 SH2125 SH1997 SH1622 SH0825 SH2186 SH2180 SH1822 SH0729 SH1015 SH1015 SH2144 SH1822 SH2125 USG721 SH1182 SH1182 SH1997 USG294 SH2186 SH1182 SH0495 SH1997 SH1997 Material Number: 420183-15 da Vinci System Numbers: SH1182 USG721 SH1997 SH1182 SH2125 SH1997 SH1368 SH1822 SH2125 SH1182 USG689 SH2144 SH1015 SH1015 SH1964 SH1368 SH1182 SH1015 SH1997 SH1964 SH1015 SH1182 SH1368 SH1182 SH1822 SH1182 SH1964 SH2186 SH1182 SH1182 SH1997 SH1997 SH1964 USG294 SH1837 SH1997 Material Number: 420183-15 da Vinci System Numbers: SH1182 USG721 SH1997 SH1182 SH2125 SH1997 SH1368 SH1822 SH2125 SH1182 USG689 SH2144 SH1015 SH1015 SH1964 SH1368 SH1182 SH1015 SH1997 SH1964 SH1015 SH1182 SH1368 SH1182 SH1822 SH1182 SH1964 SH2186 SH1182 SH1182 SH1997 SH1997 SH1964 USG294 SH1837 SH1997 Material Numbers: 420183-16 da Vinci System Number: SH1997

Recalling firm:

Intuitive Surgical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98078

Lot/product code:

Lot Code: UDI-DI: 04260102135338; 04260102135369

Recalling firm:

Heraeus Medical GmbH (Dental Division)