FDA Device recall Z-1953-2018

Sternal Valve Retractors With Atrial and Aortic Rakes

FDA Device
Class II
ongoing
Published 2018-06-06

On 2018-06-06 the FDA classified a Class II recall of Sternal Valve Retractors With Atrial and Aortic Rakes by Genesee Biomedical, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1953-2018
Classification	Class II
Status	ongoing
Initiated	2018-02-26
Published	2018-06-06
Last updated	2026-09-13 11:54 UTC
Company	Genesee Biomedical
Distribution	US

Product

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.

Reason

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.

Identifiers

code_info	Serial Numbers: 1144 1145 707 709 959 404 1114 1151 520 621 784 1156 542 694 452 455 940 433 560 941… 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 12

code_info

Serial Numbers: 1144 1145 707 709 959 404 1114 1151 520 621 784 1156 542 694 452 455 940 433 560 941…

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 12

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1953-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.