Recalls affecting Delaware

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

Recall #:

88685

Lot/product code:

Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.

Recalling firm:

Medtronic Perfusion Systems

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

Recall #:

88676

Lot/product code:

Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10; UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002190(10) 5.40.01, (01)00858164002190(10) 5.40.02, (01)00858164002268(10) 5.51.10

Recalling firm:

Elekta Inc

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

Recall #:

88874

Lot/product code:

Catalog Number: 12000651 UDI Code: 03610520652770 Lot Number: 52953

Recalling firm:

Bio-Rad Laboratories, Inc.

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

Recall #:

88874

Lot/product code:

Catalog Number: 12000650 UDI Code: 03610520653012 Lot Number: 301210

Recalling firm:

Bio-Rad Laboratories, Inc.

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

Recall #:

88784

Lot/product code:

All lots impacted

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

88784

Lot/product code:

All lots impacted

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

88719

Lot/product code:

Battery Pack Serial Numbers: 192224349IP, 191908720IP, 202369811IP, 202791944IP, 191848115IP, 192099841IP, 192103741IP, 192104141IP, 171218521PE, 181642339PE, 202321308IP, 191912520IP, 191874716IP, 191922620IP, 181642639PE, 192185446IP, 171277935PE, 192190247IP, 202400219IP, 202323808IP, 191910720IP, 181661142PE, 192245250IP, 202599332IP, 181645841PE, 181526530PE, 202403719IP, 181705244PE, 192104541IP, 191787312IP, 181646041PE, 191955422IP, 202389919IP, 191822513IP, 191853415IP, 192004724IP, 192196447IP, 192155645IP, 202330609IP, 171325749PE, 192018828IP, 191778911IP, 192187947IP, 192196247IP, 181609237PE, 192098341IP, 191972823IP, 191860615IP, 202719740IP, 202334109IP, 202651035IP, 191852615IP, 192173146IP, 202386519IP, 202398619IP, 202416720IP, 202599432IP, 191956322IP, 192205847IP, 192220349IP, 192081138IP, 202617233IP, 181659242PE, 202266705IP, 171255732PE, 192179046IP, 192179246IP, 202280605IP, 181673143PE, 192083838IP, 192106442IP, 192216649IP, 191956122IP, 181721730IP, 191943120IP, 191971023IP, 181405120PE, 181474326PE, 181440222PE, 192225649IP, 191969623IP, 192220749IP, 181706344PE, 181694644PE, 191968223IP, 202593632IP, 191863015IP, 171264133PE, 191872616IP, 181487828PE, 171337749PE, 181477426PE, 181748032IP, 191790412IP, 191902319IP, 192195547IP, 192200947IP, 191968723IP, 202552831IP, 191806513IP, 202401419IP, 191904319IP, 181492328PE, 202388319IP, 202482724IP, 192241550IP, 171339849PE, 191831214IP, 192084038IP, 181694244PE, 192210249IP, 202725540IP, 171345550PE, 171348550PE, 191915920IP, 202371511IP, 202723440IP, 202367411IP, 202279305IP, 181513630PE, 181703744PE, 202389819IP, 192175646IP, 192107842IP, 202394719IP, 202401619IP, 192204947IP, 202654636IP, 192196647IP, 192200647IP, 202782744IP. 1. Cardiosave Hybrid. Model Number (UDI Number): 0998-00-0800-31 (10607567109053), 0998-00-0800-32 (10607567111117), 0998-00-0800-33 (10607567109008), 0998-00-0800-35 (10607567109107), 0998-00-0800-36 (10607567114187), 0998-00-0800-45 (10607567108421), 0998-00-0800-52 (10607567108438), 0998-00-0800-53 (10607567108391), 0998-00-0800-55 (10607567108414), 0998-00-0800-65 (10607567113432), 0998-UC-0800-31 (10607567109053), 0998-UC-0800-33 (10607567109008), 0998-UC-0800-52 (10607567108438), 0998-UC-0800-53 (10607567108391), 0998-UC-0800-55 (10607567108414). 2. Cardiosave Rescue. Model Number: 0998-00-0800-83 (10607567108407).

Recalling firm:

Datascope Corp.

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

Recall #:

88797

Lot/product code:

UDI 03573026444204, Lot #s: 1008686690

Recalling firm:

bioMerieux, Inc.

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

Recall #:

88797

Lot/product code:

UDI 03573026620738, Lot #: 1008710950

Recalling firm:

bioMerieux, Inc.

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

Recall #:

88797

Lot/product code:

UDI 03573026161637, Lot #: 1008757880

Recalling firm:

bioMerieux, Inc.

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

Recall #:

88797

Lot/product code:

UDI 03573026156947, Lot #: 1008781470

Recalling firm:

bioMerieux, Inc.

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

Recall #:

89109

Lot/product code:

All da Vinci SP Surgical systems with software version OS4 v4.0.0 (P4_B327)

Recalling firm:

Intuitive Surgical, Inc.

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

Recall #:

89023

Lot/product code:

DigitalDiagnost C90

Recalling firm:

Philips Healthcare

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

Recall #:

88746

Lot/product code:

Serial Numbers:  US: BS16904 BS16905 BS16906 BS16909 BS16910 BS16911 BS16912 BS16913 BS16914 BS16915 BS16916 BS16917 BS16918 BS16921 BS16923 BS16925 BS17930 BS17934 BS17935 BS17936 BS17937 BS18900 BS18901 BS18924 BS18931 BS18938 BS18939 BS18940 BS18942 BS18943 BS18945 BS18946 BS18947 BS18948 BS18949 BS18950 BS18951 BS18952 BS18953 BS18954 BS18955 BS18956 BS18957 BS18958 BS18959 BS18960 BS18961 BS18962 BS18963 BS18964 BS18965 BS18966 BS18967 BS18968 BS18969 BS18970 BS18971 BS18972 BS18973 BS18974 BS18975 BS18976 BS18977 BS18979 BS18980 BS18981 BS18982 BS18983 BS18984 BS18985 BS18986 BS18987 BS18988 BS18989 BS18990 BS18991 BS18992 BS18993 BS18994 BS18995 BS18996 BS18997 BS18998 BS18999 BS19037 BS19038 BS19039 BS19040 BS19041 BS19043 BS19047 BS19049 BS19050 BS19052 BS19053 BS19054 BS19057 BS19058 BS19059 BS19060 BS19061 BS19065 BS20066 BS20067 BS20072 BS20073 BS20079 BS20080 BS20086 BS20092 BS20100 BS20103 BS20107 BS21112 BS21115 BS21121 BS21129 BS21137 BS21138  OUS:  BS15902 BS15903 BS16007 BS16919 BS16928 BS16929 BS17008 BS17010 BS17013 BS17021 BS17022 BS17023 BS18024 BS18026 BS18027 BS18028 BS18030 BS18031 BS19032 BS19033 BS19034 BS19035 BS19036 BS19042 BS19051 BS19056 BS19062 BS19064 BS20068 BS20069 BS20070 BS20071 BS20074 BS20075 BS20076 BS20077 BS20078 BS20082 BS20084 BS20085 BS20090 BS20095 BS20098 BS20099 BS20102 BS20105 BS20106 BS21108 BS21109 BS21114 BS21124 BS21128 BS21132 BS21133 BS21134

Recalling firm:

MEDTECH SAS

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

Recall #:

88797

Lot/product code:

UDI 03573026223601, Lot #s: 1008603580, 1008748010, 1008888030, 1008584190, 1008647850

Recalling firm:

bioMerieux, Inc.

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

Recall #:

88797

Lot/product code:

UDI 03573026387006, Lot #s: 1008696660,1008761020, 1008864290, 1008891690

Recalling firm:

bioMerieux, Inc.

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

Recall #:

88797

Lot/product code:

UDI 03573026138585, Lot #: 1008694980, 1008700260, 1008828980

Recalling firm:

bioMerieux, Inc.

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

Recall #:

88797

Lot/product code:

UDI 03573026458270, Lot #: 1008714880, 1008824220

Recalling firm:

bioMerieux, Inc.

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

Recall #:

89023

Lot/product code:

ProxiDiagnost N90

Recalling firm:

Philips Healthcare

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

Recall #:

88797

Lot/product code:

UDI 03573026447151, Lot #: 1008636750, 1008768920, 1008857410

Recalling firm:

bioMerieux, Inc.

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

Recall #:

89023

Lot/product code:

CombiDiagnost R90

Recalling firm:

Philips Healthcare

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

Recall #:

88797

Lot/product code:

UDI 03573026229146, Lot #s: 1008730880

Recalling firm:

bioMerieux, Inc.

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

Recall #:

88797

Lot/product code:

UDI 03573026064525, Lot #: 1008769120

Recalling firm:

bioMerieux, Inc.

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

Recall #:

88797

Lot/product code:

UDI 03573026263010, Lot #: 1008861590

Recalling firm:

bioMerieux, Inc.

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

Recall #:

88797

Lot/product code:

UDI 03573026064532, Lot #: 1008890110

Recalling firm:

bioMerieux, Inc.