Recalls affecting Montana

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

Recall #:

92945

Lot/product code:

UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.

Recalling firm:

Icecure Medical Ltd

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

Recall #:

84595

Lot/product code:

Lot number(s) : 18G0368; 19H0009; 18F0138; 18G0038

Recalling firm:

Medicrea International

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

Recall #:

83847

Lot/product code:

List Number 03R69 03 & 03R69 04, All Serial Numbers

Recalling firm:

Abbott Gmbh & Co. KG

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

Recall #:

83847

Lot/product code:

List Number 04S68-02, All Serial Numbers

Recalling firm:

Abbott Gmbh & Co. KG

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

Recall #:

84043

Lot/product code:

UDI: 05055845400282; Lot Numbers 902924530, 902925703

Recalling firm:

Axis-Shield Diagnostics, Ltd.

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

Recall #:

83847

Lot/product code:

List Number 03R66 03, All Serial Numbers

Recalling firm:

Abbott Gmbh & Co. KG

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

Recall #:

85271

Lot/product code:

Polaris 2.10 software version (disk batch 629774); iLab Polaris Systems affected product listing (serial numbers): 200204, 200209, 200217, 200308, 200310, 200448, 200450, 200456, 200457, 200458, 200461,200480, 200481, 200103, 200145, 200044, 200118, 200360, 200498, 200170, 8361, 10312, 10443, 10548, 7402, 8397, 8497, 8498, 8508, 8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278,10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 7402, 8397, 8497, 8498, 8508, 8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278, 10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 7402, 8397, 8497, 8498, 8508, 8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278, 10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 6582 , 7023, 7857, 5637, 5716, 6650, 6894, 4031, 5003, 5043, 5060, 5109, 5232, 5239, 5393, 5465, 5651, 5678, 5860, 6193, 6350, 8264, 6819, 6921, 6934, 7332, 7341, 7362, 7733, 7828, 7858, 7933, 7934, 8011, 8155, 8290, 6383, 5182, 5219, 5296, 5398, 8157, 6760, 7723, 10108, 8365, 8367, 10504, 10657, 10501, 4274, 8046, 8048, 5892, 7818, 4773, 5585, 8113, 5165, 4402, 6468, 6319, 5313, 7511, 4952, 5277, 5457, 4116, 5403, 5078, 5664, 5666, 6327, 6733, 6994, 6136, 6206, 6172, 7604, 7602, 7353, 6273, 6993, 4045, 10221, 10261, and 8540.

Recalling firm:

Boston Scientific Corporation

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

Recall #:

83869

Lot/product code:

All serial numbers sold between 01/21/2015 - 04/30/2019

Recalling firm:

Pacific Medical Group Inc.

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

Recall #:

D-0121-2020

Lot/product code:

Lot 4DU2E009

Recalling firm:

Torrent Pharma Inc.

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

Recall #:

83869

Lot/product code:

All serial numbers sold between 01/21/2015 - 04/30/2019

Recalling firm:

Pacific Medical Group Inc.

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

Recall #:

83869

Lot/product code:

All serial numbers sold between 10/24/2014 - 04/30/2019

Recalling firm:

Pacific Medical Group Inc.

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

Recall #:

D-0124-2020

Lot/product code:

Lot 4P04D007

Recalling firm:

Torrent Pharma Inc.

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

Recall #:

83869

Lot/product code:

All serial numbers sold between 01/21/2015 - 04/30/2019

Recalling firm:

Pacific Medical Group Inc.

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

Recall #:

83869

Lot/product code:

All serial numbers sold between 01/21/2015 - 04/30/2019

Recalling firm:

Pacific Medical Group Inc.

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

Recall #:

D-0122-2020

Lot/product code:

Count, lot, expiry: [90 count] Lot 4DU3E009, exp 12/31/2020; [1000 count] Lot 4DU3D018, exp 02/28/2021

Recalling firm:

Torrent Pharma Inc.

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

Recall #:

83869

Lot/product code:

All serial numbers distributed between 02/06/16 - 04/30/19.

Recalling firm:

Pacific Medical Group Inc.

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

Recall #:

D-0123-2020

Lot/product code:

Lot BEF7D051

Recalling firm:

Torrent Pharma Inc.

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

Recall #:

83869

Lot/product code:

All serial numbers sold between 02/06/2016 - 04/30/2019

Recalling firm:

Pacific Medical Group Inc.

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:

D-0166-2020

Lot/product code:

Lot #: NBSB19001DA3, Exp. date 02/2021

Recalling firm:

AuroMedics Pharma LLC

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

Recall #:

D-0314-2020

Lot/product code:

All lots remaining within expiry.

Recalling firm:

Apotex Inc.

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

Recall #:

85240

Lot/product code:

Software Versions (UDI/GTIN): MOSAIQ 2.00 (00858164002305); MOSAIQ 2.20 (00858164002312); MOSAIQ 2.30 (00858164002329); MOSAIQ 2.40 (00858164002077); MOSAIQ 2.41 (00858164002084); MOSAIQ 2.60 -2.64 (00858164002091); MOSAIQ 2.50 (00858164002107); MOSAIQ 2.65 (00858164002220); MOSAIQ 2.70 (00858164002037); MOSAIQ 2.80 (00858164002251); MOSAIQ 2.81 (00858164002282)

Recalling firm:

Elekta Impac Software

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

Recall #:

D-0319-2020

Lot/product code:

All lots remaining within expiry.

Recalling firm:

Apotex Inc.

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

Recall #:

D-0318-2020

Lot/product code:

All lots remaining within expiry.

Recalling firm:

Apotex Inc.

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

Recall #:

D-0315-2020

Lot/product code:

All lots remaining within expiry.

Recalling firm:

Apotex Inc.

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

Recall #:

D-0317-2020

Lot/product code:

All lots remaining within expiry.

Recalling firm:

Apotex Inc.