BIGNOPE
Ko-fi

Recalls affecting North Dakota

Data last updated: September 8, 2026 at 1:13 PM UTC

16,332 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

▸Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
NewestOldest
High riskLow riskAll
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled February 8, 2018

POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

ALL 50 STATES
▸Full report

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

Recall #:
79841
Lot/product code:
Lot Number Unique Device Identifier (UDI) REAN0067 (01)00801741110825(17)170628(10)REAN0067 REAP0630 (01)00801741110825(17)170728(10)REAP0630 REAS2309 (01)00801741110825(17)171028(10)REAS2309 REAV2088 (01)00801741110825(17)171028(10)REAV2088 REAY0330 (01)00801741110825(17)171031(10)REAY0330 REBS1275 (01)00801741110825(17)180731(10)REBS1275 REBT1568 (01)00801741110825(17)181031(10)REBT1568 REBV0713 (01)00801741110825(17)181231(10)REBV0713
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 8, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

ALL 50 STATES
▸Full report

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

Recall #:
79841
Lot/product code:
Lot Number Unique Device Identifier (UDI) REAN0055 (01)00801741110771(17)170628(10)REAN0055 REAN0202 (01)00801741110771(17)170528(10)REAN0202 REAP0771 (01)00801741110771(17)170828(10)REAP0771 REAS1708 (01)00801741110771(17)171028(10)REAS1708 REAT0147 (01)00801741110771(17)171128(10)REAT0147 REAT1852 (01)00801741110771(17)171228(10)REAT1852 REAU1811 (01)00801741110771(17)171228(10)REAU1811 REAU2420 (01)00801741110771(17)171228(10)REAU2420 REAV2465 (01)00801741110771(17)180228(10)REAV2465 REAW1422 (01)00801741110771(17)180331(10)REAW1422 REAW1831 (01)00801741110771(17)180331(10)REAW1831 REAX1132 (01)00801741110771(17)180331(10)REAX1132 REAY1623 (01)00801741110771(17)180331(10)REAY1623 REAY2597 (01)00801741110771(17)180331(10)REAY2597 REBP0090 (01)00801741110771(17)180331(10)REBP0090 REBS1269 (01)00801741110771(17)181031(10)REBS1269 REBR1002 (01)00801741110771(17)181031(10)REBR1002 REBS1439 (01)00801741110771(17)181031(10)REBS1439 REBT1052 (01)00801741110771(17)181231(10)REBT1052 REBT2348 (01)00801741110771(17)181231(10)REBT2348 REBV0714 (01)00801741110771(17)190131(10)REBV0714 REBV1758 (01)00801741110771(17)190131(10)REBV1758 REBW1288 (01)00801741110771(17)190331(10)REBW1288 REBX1628 (01)00801741110771(17)190331(10)REBX1628 REBX2052 (01)00801741110771(17)190430(10)REBX2052
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 8, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

ALL 50 STATES
▸Full report

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

Recall #:
79841
Lot/product code:
Lot Number Unique Device Identifier (UDI) REAN0061 (01)00801741110818(17)170628(10)REAN0061 REAP0772 (01)00801741110818(17)170728(10)REAP0772 REAT1524 (01)00801741110818(17)171128(10)REAT1524 REAV1479 (01)00801741110818(17)171228(10)REAV1479 REAV1938 (01)00801741110818(17)171028(10)REAV1938 REAW0937 (01)00801741110818(17)171031(10)REAW0937 REAW1186 (01)00801741110818(17)171031(10)REAW1186 REAW1666 (01)00801741110818(17)171031(10)REAW1666 REAY0528 (01)00801741110818(17)171031(10)REAY0528 REAY0795 (01)00801741110818(17)171031(10)REAY0795 REAZ1529 (01)00801741110818(17)171231(10)REAZ1529 REBN0024 (01)00801741110818(17)171231(10)REBN0024 REBN1581 (01)00801741110818(17)180131(10)REBN1581 REBQ0210 (01)00801741110818(17)180131(10)REBQ0210 REBS1277 (01)00801741110818(17)181031(10)REBS1277 REBR1125 (01)00801741110818(17)181031(10)REBR1125 REBS1395 (01)00801741110818(17)181031(10)REBS1395 REBS2412 (01)00801741110818(17)181130(10)REBS2412 REBT1785 (01)00801741110818(17)181231(10)REBT1785 REBT2349 (01)00801741110818(17)181231(10)REBT2349 REBU0563 (01)00801741110818(17)181231(10)REBU0563 REBV0760 (01)00801741110818(17)190228(10)REBV0760 REBW1037 (01)00801741110818(17)190331(10)REBW1037
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 8, 2018

POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

ALL 50 STATES
▸Full report

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

Recall #:
79841
Lot/product code:
Lot Number Unique Device Identifier (UDI) REAN0059 (01)00801741110757(17)170628(10)REAN0059 REAN1125 (01)00801741110757(17)170628(10)REAN1125 REAP0627 (01)00801741110757(17)170728(10)REAP0627 REBN2011 (01)00801741110757(17)180131(10)REBN2011 REBP0853 (01)00801741110757(17)180131(10)REBP0853 REBS1276 (01)00801741110757(17)181031(10)REBS1276 REBS2291 (01)00801741110757(17)181130(10)REBS2291 REBU1357 (01)00801741110757(17)181231(10)REBU1357 REBW1455 (01)00801741110757(17)190331(10)REBW1455 REBY0778 (01)00801741110757(17)190430(10)REBY0778
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 8, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

ALL 50 STATES
▸Full report

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

Recall #:
79841
Lot/product code:
Lot Number Unique Device Identifier (UDI) REAN0066 (01)00801741110795(17)170528(10)REAN0066 REAP0629 (01)00801741110795(17)170728(10)REAP0629 REAY1483 (01)00801741110795(17)180531(10)REAY1483 REAY2494 (01)00801741110795(17)180331(10)REAY2494 REBS0163 (01)00801741110795(17)181031(10)REBS0163 REBT0364 (01)00801741110795(17)181130(10)REBT0364 REBT1664 (01)00801741110795(17)181231(10)REBT1664 REBT2149 (01)00801741110795(17)181231(10)REBT2149 REBW0874 (01)00801741110795(17)190331(10)REBW0874 REBY1231 (01)00801741110795(17)190430(10)REBY1231
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled February 21, 2018

Emerald brand Glazed Walnuts; Net WT. 6.5 OZ; Re-sealable pouch

Snyder's Lance is voluntarily recalling 6.5 oz. Emerald brand walnuts due to the presence of not listed on the label peanuts, almonds, cashews, and pecans.

ALL 50 STATES
▸Full report

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

Recall #:
F-0884-2018
Lot/product code:
Best Before DEC 15 2018; Lot Code: EN1216XX2; Package UPC: 010300808947; Case UPC: 010300930648;
Recalling firm:
Snyder's-Lance Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 21, 2018

True 3D Viewer, Model: EP-00003

With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image orientation, which could result in misdiagnosis or incorrect surgical treatment plan.

ALL 50 STATES
▸Full report

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

Recall #:
96674
Lot/product code:
UDI-DI: 00851325007003. Full release software versions: 1.6.1.3080.428, released 13-Apr-2017 1.6.2.3670.435, released 07-Dec-2017 Develop Versions, for research use: 0.00.2695.422, released 15-Feb-2017 0.00.2927.423, released 15-Feb-2017 0.00.2964.423, released 24-Feb-2017 0.00.3102.428, released 04-Apr-2017 0.00.3245.428, released 05-May-2017 0.00.3302.431, released 02-Jun-2017 0.00.3344.432, released 18-Jul-2017 0.00.3412.433, released 14-Aug-2017 0.00.3656.442, released 09-Nov-2017 0.00.3669.442, released 05-Dec-2017 0.00.3683.445, released 02-Jan-2018 0.00.3702.447, released 11-Jan-2018 0.00.3730.447, released 08-Feb-2018
Recalling firm:
Echopixel, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2018

Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.

ALL 50 STATES
▸Full report

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

Recall #:
80024
Lot/product code:
Serial Numbers: 1144 1145 707 709 959 404 1114 1151 520 621 784 1156 542 694 452 455 940 433 560 941 718 388 960 808 1045 1007 479 484 473 390 1067 1071 469 470 1054 977 626 967 494 1140 450 783 1194 853 920 273 368 1120 1121 1126 770 773 949 950 475 1021 1022 1159 877 680 769 370 1057 751 790 665 1092 1028 1118 981 585 586 582 993 1019 995 660 1094 1000 1001 1002 1003 1004 1034 1035 440 654 684 918 957 982 996 998 997 558 841 843 1100 238 731 369 854 526 187 489 568 695 992 677 1143 815 366 1182 1077 905 1044 1134 1046 564 1026 676 1040 1066 516 726 363 389 939 971 559 852 1080 566 599 600 522 1124 1150 628 629 909 796 990 903 916 917 1125 834 836 376 377 262 456 457 1115 490 1139 1160 774 789 822 833 476 403 1161 1164 1178 766 786 538 849 1078 1088 1093 451 471 782 215 356 807 1048 1073 937 1122 624 1225 591 1090 649 817 819 174 261 745 653 581 835 367 816 929 875 891 901 1123 804 842 933 578 434 1132 1133 923 787 375 912 924 1112 1136 1179 1180 619 620 637 675 708 801 947 571 572 573 1036 1085 951 1113 1165 1168 1170 1176 1177 562 651 797 814 826 828 829 926 931 935 540 551 552 679 803 794 553 678 802 811 812 813 821 686 954 1089 1138 595 598 721 757 907 908 910 911 913 1135 567 622 625 638 652 765 800 889 922 927 928 442 445 446 447 519 545 823 449 458 459 460 461 1006 1074 1076 362 430 570 948 255 477 1142 256 472 710 738 958 976 492 974 402 409 856 1025 1027 1079 1127 1128 1119 915 574 643 644 740 741 742 743 771 839 1037 956 1038 1039 1047 1049 1050 1051 1052 1053 1055 1056 1075 1091 1104 1105 513 521 525 557 575 584 590 627 674 735 785 809 810 827 844 846 847 876 887 925 932 934 942 943 945 970 983 994 596 632 720 724 725 744 754 762 969 968 1024 1116 1115 1154 855 878 636 640 641 495 491 425 1069 1070 900 904 767 768 664 761 763 764 699 706 696 698 648 645 646 647 630 569 527 499 357 359 360 272 443 444 840 845 848 1058 1059 1064 1065 1146 1153 1167 1169 1171 1172 1173 1175
Recalling firm:
Genesee BioMedical, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled March 6, 2018

Maurice's Honey Southern Gold BBQ Sauce; Net Wt. 18 oz. bottles; UPC Code 0 7561654332 6 and Carolina Gold Honey Sauce; Net Wt. 18 oz. bottle; UPC Code 0 7561654383 8

Not listed on the label soy and wheat ingredients

ALL 50 STATES
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
F-0978-2018
Lot/product code:
All lots
Recalling firm:
Piggie Park Enterprises Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 7, 2018

Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B

Recalling firm was informed that as a result of combination of a weak spring and incorrect alignment of the locking pin for latching the leg positions, product legs folded inwards while lifting a person off a bed and the individual was dropped.

ALL 50 STATES
▸Full report

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

Recall #:
79627
Lot/product code:
All Lots
Recalling firm:
Autochair
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 12, 2018

Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.

After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.

ALL 50 STATES
▸Full report

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

Recall #:
78599
Lot/product code:
Product No. 160005  All Serial Numbers
Recalling firm:
Hamilton Medical AG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 12, 2018

Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.

After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.

ALL 50 STATES
▸Full report

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

Recall #:
78599
Lot/product code:
Product No. 160001  All Serial Numbers.
Recalling firm:
Hamilton Medical AG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2018

HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.

Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid.

ALL 50 STATES
▸Full report

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

Recall #:
83268
Lot/product code:
All lots of RF assay
Recalling firm:
Hycor Biomedical Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusRecalled March 21, 2018

GFS Belgian Mini Chocolate Topped Eclairs, Keep Frozen, Net Wt . 700 g.; Signature Select Belgian Style Mini Eclairs, Keep Frozen, 420 g; Delizza Patisserie Belgian Custard Cream Mini Eclairs, 420 g.

Products may be contaminated with Listeria monocytogenes

ALL 50 STATES
▸Full report

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

Recall #:
F-1141-2018
Lot/product code:
GFS Product UPC 093901859372, Lot code: L1D1018, Best Before 09/06/19; Signature Select UPC 021130085460, Lot code: L1G1018, Best Before 09/07/19; Delizza UPC 676670001069; Lot code: L1M1018, Best Before 09/09/19
Recalling firm:
Poppies International INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 2, 2018

PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagnostic analysis of samples from the human body to obtain information oh physiological and pathological states.

The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other component and, if incorrectly connected, could result in irreparable damage to the system.

ALL 50 STATES
▸Full report

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

Recall #:
80403
Lot/product code:
UDI: 00847865014151  Serial Numbers: 140600072,  160900991,  161001953,  1112001938,  1112001941 ,  1112004075 ,  1112004079 ,  1112004083 ,  1112004084 ,  1112004086 ,  1112004088 ,  1112004093 ,  1201003822 ,  1201003826 ,  1201003827 ,  1207001007 ,  1207001015 ,  1207001017 ,  1207001018 ,  1208001583 ,  1208001584 ,  1208001586 ,  1208001590 ,  1208005236 ,  1208005244 ,  1208005245 ,  1211000978 ,  1211000983 ,  1211006938 ,  1301003205 ,  1301003212 ,  1303000299 ,  1303000300 ,  1303000302 ,  1303000305 ,  1303007688 ,  1306003195 ,  1307006044 ,  1307006045 ,  1307006054 ,  1307006055 ,  1308000967 ,  1308000968 ,  1308000969 ,  1308000971 ,  1308000973 ,  1308003338 ,  1308003341 ,  1308003345 ,  1308003346 ,  1308006670 ,  1311008542 ,  1311008544 ,  1311008546 ,  1311008555 ,  1311008557 ,  1311008562 ,  1311008564 ,  1311008565 ,  1401002580 ,  1401002583 ,  1401002587 ,  1401007785 ,  1401007786 ,  1401007789 ,  1401007792 ,  1401007793 ,  1404000065 ,  1404000066 ,  1404000067 ,  1404000068 ,  1404002677 ,  1404002684 ,  1404002685 ,  1405005640 ,  1405005641 ,  1405005645 ,  1405005648 ,  1406000064 ,  1406000065 ,  1406000066 ,  1406000067 ,  1406000068 ,  1406000070 ,  1406000071 ,  1406000074 ,  1406006883 ,  1406006886 ,  1407004144 ,  1407004145 ,  1407004147 ,  1407004149 ,  1407004151 ,  1407004152 ,  1410010410 ,  1410010415 ,  1410010416 ,  1411010876 ,  1411010877 ,  1411010880 ,  1412001714 ,  1412001716 ,  1412001721 ,  1501001523 ,  1501001526 ,  1501001526 ,  1501005823 ,  1501005824 ,  1501005825 ,  1501005828 ,  1501005829 ,  1501005832 ,  1506008687 ,  1506008690 ,  1506008695 ,  1510005389 ,  1510005393 ,  1510005394 ,  1510005395 ,  1510005397 ,  1510005398 ,  1510005399 ,  1510005414 ,  1601001552 ,  1601001553 ,  1601001559 ,  1601001561 ,  1601001562 ,  1601001563 ,  1603001786 ,  1603005407 ,  1605000088 ,  1609000992 ,  1609000993 ,  1609000994 ,  1609000995 ,  1609000996 ,  1609001301 ,  1609001302 ,  1609001303 ,  1609001304 ,  1609001305 ,  1609001306 ,  1609009231 ,  1610001955 ,  1701001785 ,  1701001788 ,  1701004204 ,  1701004210 ,  1710010533 ,  1710010539 ,  13060003204 ,  16303005411 ,  s1411010876
Recalling firm:
Bio-Rad Laboratories Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 4, 2018

Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.

Tip of the curing light was too hot causing a heat sensation in the patients.

ALL 50 STATES
▸Full report

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

Recall #:
81459
Lot/product code:
Serial #17C0001 to #17C0252
Recalling firm:
Handpiece Headquarters
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 6, 2018

EasyTouch (ET) Insulin Syringe 29G 0.5ml " (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

The retail shelf cartons may be labeled with an incorrect lot number.

ALL 50 STATES
▸Full report

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

Recall #:
79950
Lot/product code:
Lot 45016
Recalling firm:
MHC Medical Products LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 6, 2018

EasyTouch (ET) Insulin Syringe 29G 1ml " (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

The retail shelf cartons may be labeled with an incorrect lot number.

ALL 50 STATES
▸Full report

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

Recall #:
79950
Lot/product code:
Lot 45014
Recalling firm:
MHC Medical Products LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 2, 2018

Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.

Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.

ALL 50 STATES
▸Full report

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

Recall #:
80056
Lot/product code:
ALL SERIAL NUMBERS  UPN/GTIN: (a) 1400 and 1401: distributed prior to GTN requirement  1403: 00888707000116, 00888707000475  1407: '00888707000291, '00888707000727, '00888707000710,   00888707000734, '00888707000741, '00888707000765, '00888707000758, '00888707000789, '00888707000772, '00888707000499, '00888707000796, '00888707000802, '00888707000819, '00888707000482, '00888707004534, '0888707001670, '00888707001656, '00888707001663, '00888707001670, '00888707001687, '00888707001694, '00888707001700, '00888707001717, '00888707001724, '00888707001731, '00888707001748, '00888707001755, '00888707001762, '00888707002813, '00888707002820, '00888707002837, '00888707002844, '00888707002851, '00888707001472  1420: '00888707000420, '00888707000437, '00888707002660  (b) 1435: '00888707000109  1440: '00888707000260, '00888707001885, '00888707001496,  '00888707002745  (c) 1425: '00888707000093  1430: '00888707000307, '00888707000826, '00888707000833,  '00888707000840, '00888707000857, '00888707000871, '00888707000864,  '00888707000888, '00888707000901, '00888707000505, '00888707000895,  '00888707000918, '00888707001489, '00888707001779, '00888707001786,  '00888707001793, '00888707001809, '00888707001816, '00888707001823,  '00888707001830, '00888707001847, '00888707001854, '00888707001861,  '00888707001878, '00888707002738, '00888707002769, '00888707002776,  '00888707002783, '00888707002790, '00888707002806, '00888707004817  (d) 1650DE: 00888707000369, 00888707001373, '00888707001588, '00888707001366, '00888707002684 '00888707002646, '00888707002653,  '00888707000376
Recalling firm:
Heartware
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 3, 2018

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179

Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.

AKALARAZCACOCTDCDEFLGAGUHIIAIDILINKSKYLAMAMDMEMIMNMOMSNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
80003
Lot/product code:
All Serial Numbers distributed from 03/06/2012 to 04/26/2018
Recalling firm:
Maquet Datascope Corp - Cardiac Assist Division
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2018

The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.

An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.

ALL 50 STATES
▸Full report

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

Recall #:
80691
Lot/product code:
UDI Number: 00886874114193. Serial Number: SK1703.
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology, Item Code EGIA45CTAVM

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
▸Full report

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

Recall #:
80423
Lot/product code:
N7L1041KX & N8A0199KX
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
▸Full report

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

Recall #:
80423
Lot/product code:
N7G0756KX & N7L0819KX
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30ACTAVM

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
▸Full report

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

Recall #:
80423
Lot/product code:
N7L1163X & N7M0156X
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
▸Full report

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

Recall #:
80423
Lot/product code:
N7L0915X & N7M0468X
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)