Sternal Valve Retractors With Atrial and Aortic Rakes
Medical device recall Z-1953-2018. Published in FDA’s Enforcement Report on Jun 6, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 6, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 444 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
444 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,915 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution. US nationwide, South Korea, Australia, COSTA RICA, Taiwan, New Zealand, Italy, Canada, Netherlands, Norway, Sweden, Switzerland, Israel, Japan, Egypt, South Africa, United Kingdom
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 26, 2018.
- FDA classified it on May 29, 2018.
- FDA’s Enforcement Report published it on Jun 6, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Genesee BioMedical, Inc., of Denver, CO.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.