Recalls affecting Michigan

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

Recall #:

99467

Lot/product code:

UDI: 10705034645995/Serial Numbers: W14316295301 W15316297501 W15316298001 W17316322901 W17316323301 W21316347401 W21316347501 W21316347601 W21316347801 W21316347901 W21316348001 W22316365801 W34316479001 W34316479101 W34316479201 W34316479301 W34316479401 W34316479601 W34316479801 W34316480001 W34316480101 W49316554301 W51316597001 W51316597101 Y03316603601 Y03316603701 Y03316603801 Y07316625901 Y15316690901

Recalling firm:

Medos International Sarl

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

Recall #:

D-0733-2026

Lot/product code:

Batch # DMC125018A, Exp Date: 07/2027.

Recalling firm:

Aurobindo Pharma USA Inc

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

Recall #:

D-0731-2026

Lot/product code:

Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.

Recalling firm:

Glenmark Pharmaceuticals Inc., USA

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

Recall #:

D-0730-2026

Lot/product code:

Lot # DLHU0031, Exp Date: 06/30/2027.

Recalling firm:

MICRO LABS USA INC

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

Recall #:

99529

Lot/product code:

UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38

Recalling firm:

FUJIFILM Healthcare Americas Corporation

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

Recall #:

99520

Lot/product code:

Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409

Recalling firm:

Merge Healthcare, Inc.

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

Recall #:

99561

Lot/product code:

UDI-DI 10193489431070 Lots 25BBB005 25GBY063 25KBI862 25LBT688 26CBG211

Recalling firm:

Medline Industries, LP

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

Recall #:

99404

Lot/product code:

Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark IQecg Digital ECG. The Midmark IQecg Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 480000 4820704 UDI-DI: 00841709100581, 00841709100321, 00841709100895, 00841709100901

Recalling firm:

Midmark Corporation

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

Recall #:

99404

Lot/product code:

Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark Digital ECG. The Midmark Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 7817519 7817645, L1130587 V2967564 UDI-DI: 00841709121319, 08056732652491

Recalling firm:

Midmark Corporation

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

Recall #:

99536

Lot/product code:

GTIN 00195278679284, Serial Numbers: SWT25250001TA, SWT25360001TA, SWT25360002TA, SWT24090006TA, SWT25100001TA, SWT25120002TA, SWT24140007TA, SWT24150008TA, SWT25100004TA, SWT24050001TA, SWT25110003TA, SWT24180011TA, SWT25120003TA, SWT25230001TA, SWT25230002TA, SWT25110009TA, SWT25110010TA, SWT25230003TA, SWT25230005TA, SWT25230006TA, SWT25230004TA, SWT25260001TA, SWT31240012TA.

Recalling firm:

GE Medical Systems Information Technologies Inc

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

Recall #:

99561

Lot/product code:

CDS981762B UDI-DI 10193489306767 Lots 24JBE456 24JBN932 24KBJ154 25ABK513 25CBL684 25HBK086 25IBM188 25KBL720 25LBF812 25LBU497 26ABM665 26CBH544 26CBT272 26FBK806 DYKA1054F UDI-DI 10193489312607 Lots 24ILA823 24JLA285 24LLA226 24LLB033 25BLA842 25ELA624 25GLA270 25HLB055 25KLA019 25KLA187 26BLA150 26CLA717 26DLA410 26ELA772 26FLA756

Recalling firm:

Medline Industries, LP

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

Recall #:

99404

Lot/product code:

Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark Digital ECG. The Midmark Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 7817519 7817645, L1130587 V2967564 UDI-DI: 00841709121319, 08056732652491

Recalling firm:

Midmark Corporation

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

Recall #:

99561

Lot/product code:

DYKS2018 UDI-DI 10198459188480 Lot 25GMI043 DYKS1584A UDI-DI 10198459146633 Lots 24JBA740 25ABF244 DYKS1216I UDI-DI 10198459362668 Lots 25GBP888 25JBD789 26ABL474 26CBF334 26DBD640 26EBB855 26FBC632 DYKM1398B UDI-DI 10198459413827 Lots 25HBI183 25JBK222 25KBA990 25LBJ990 26BBI525 26CBJ249 26EBQ630 26FMF189

Recalling firm:

Medline Industries, LP

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

Recall #:

99561

Lot/product code:

DYKA1384B UDI-DI 10198459415753 Lot 25GBS617 DYKA1384C UDI-DI 10198459485206 Lot 25IBF898 DYKS1206D UDI-DI 10198459414794 Lots 25HBI181 25JBJ452 25LBJ223 26ABT372 26CBF527 26EBH733

Recalling firm:

Medline Industries, LP

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

Recall #:

99536

Lot/product code:

GTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA.

Recalling firm:

GE Medical Systems Information Technologies Inc

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

Recall #:

99561

Lot/product code:

UDI-DI 10198459362835 Lots 25IBJ918 25KBN677 25LBU066 26BBD775

Recalling firm:

Medline Industries, LP

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

Recall #:

99476

Lot/product code:

All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2

Recalling firm:

Paragonix Technologies Inc.

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

Recall #:

99561

Lot/product code:

CDS860014Q UDI-DI 10198459629822 Lots 26ABR359 26BBP789 26CBL940 26DBK987 26FBK255 26FBK816 DYKM1000B UDI-DI 10889942508143 Lots 24KMD782 24LMH404 25AMD765 25BMD744 CDS860014P UDI-DI 10888277797819 Lots 24IBA155 24JBY045 24LBM014 25HBR509 25JBX951 DYNDV2684 UDI-DI 10198459185465 Lot 24LBP243

Recalling firm:

Medline Industries, LP

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

Recall #:

99404

Lot/product code:

Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark IQecg Digital ECG. The Midmark IQecg Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 480000 4820704 UDI-DI: 00841709100581, 00841709100321, 00841709100895, 00841709100901

Recalling firm:

Midmark Corporation

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

Recall #:

99561

Lot/product code:

DYKS1583A UDI-DI 10198459146640 Lot 24KBP388

Recalling firm:

Medline Industries, LP

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

Recall #:

99561

Lot/product code:

DYNDH1487A UDI-DI 10193489484311 Lots 25AMD225 25BMA495 25GMD834 25HMJ685 26AMD781 26DMI370 26FMG952 26FMJ739

Recalling firm:

Medline Industries, LP

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

Recall #:

99322

Lot/product code:

UDI:9336472005542; Serial Numbers 0003-1533

Recalling firm:

SDI Limited

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

Recall #:

99536

Lot/product code:

UDI-DI (GTIN) 00195278679307

Recalling firm:

GE Medical Systems Information Technologies Inc

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

Recall #:

99561

Lot/product code:

UDI-DI 10889942925858 Lot 26EBI940

Recalling firm:

Medline Industries, LP

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

Recall #:

99561

Lot/product code:

CDS983348AA UDI-DI 10195327385088 Lots 24IBK346 24JBK539; CDS983348AB UDI-DI 10198459136986 Lots 25CBF097 25HBB232 25HBB761 25HBH209 25HBU907 25JBQ176

Recalling firm:

Medline Industries, LP