DeRoyal Industries Inc Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK, REF '89-4479; i) BREAST PACK, REF '89-5424; j) SHOULDER ARTHROSCOPY PK, REF '89-6606; k) GYN PACK, REF '89-7369; l) ENT PACK, REF '89-7378; m) TOTAL HIP PACK PGYBK, Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK, REF '89-4479; i) BREAST PACK, REF '89-5424; j) SHOULDER ARTHROSCOPY PK, REF '89-6606; k) GYN PACK, REF '89-7369; l) ENT PACK, REF '89-7378; m) TOTAL HIP PACK PGYBK,
Brand
DeRoyal Industries Inc
Lot Codes / Batch Numbers
a) REF '53-1941, GTIN 50749756864676 (cs), 00749756864671 (unit), Lot Numbers: 59095817, 59108518, 59132841, 59153079, 59169847, 59185134, 59216471, 59224383, b) REF '89-10045, GTIN 50749756980123 (cs), 00749756980128 (unit), Lot Numbers: 58714313, c) REF '89-10115, GTIN 50749756977901 (cs), 00749756980128 (unit), Lot Numbers: 58746278, d) REF '89-10213, GTIN 50749756350131 (cs), 00749756350136 (unit), Lot Numbers: 58745371, e) REF '89-10505, GTIN 50749756363124 (cs), 00749756363129 (unit), Lot Numbers: 58774885, 58774885, f) REF '89-10563, GTIN 50749756363988 (cs), 00749756363983 (unit), Lot Numbers: 58800174, g) REF '89-1495, GTIN 50749756214730 (cs), 00749756214735 (unit), Lot Numbers: 58762104, h) REF '89-4479, GTIN 50749756591527 (cs), 00749756591522 (unit), Lot Numbers: 58810330, i) REF '89-5424, GTIN 50749756636730 (cs), 00749756636735 (unit) Lot Numbers: 58698974, j) REF '89-6606, GTIN 50749756686421 (cs), 00749756686426 (unit) Lot Numbers: 58698907, k) REF '89-7369, GTIN 50749756736690 (cs), 00749756736695 (unit) Lot Numbers: 58777761, l) REF '89-7378, GTIN 50749756736409 (cs), 00749756736404 (unit) Lot Numbers: 58811834, m) REF '89-7540, GTIN 50749756741410 (cs), 00749756741415 (unit), Lot Numbers: 58737081, n) REF '89-8061, GTIN 50749756807291 (cs), 00749756807296 (unit), Lot Numbers: 58698042, o) REF '89-8187, GTIN 50749756818488 (cs), 00749756818483 (unit), Lot Numbers: 58736862, p) REF '89-8439, GTIN 50749756836925 (cs), 00749756836920 (unit), Lot Numbers: 58823595, q) REF '89-8445, GTIN 50749756840090 (cs), 00749756840095 (unit) Lot Numbers: 58697963, r) REF '89-8482, GTIN 50749756848331 (cs), 00749756848336 (unit), Lot Numbers: 58789411, s) REF '89-9131, GTIN 50749756945030 (cs), 00749756945035 (unit) Lot Numbers: 58808416, t) REF '89-9287, GTIN 50749756938001 (cs), 00749756938006 (unit) Lot Numbers 58789260, u) REF '89-9626, GTIN 50749756927661 (cs), 00749756927666 (unit) Lot Numbers: 58738315 v) REF '89-9632, GTIN 50749756927593 (cs), 00749756927598 (unit) Lot Numbers: 58701598
Products Sold
a) REF '53-1941, GTIN 50749756864676 (cs), 00749756864671 (unit), Lot Numbers: 59095817, 59108518, 59132841, 59153079, 59169847, 59185134, 59216471, 59224383; b) REF '89-10045, GTIN 50749756980123 (cs), 00749756980128 (unit), Lot Numbers: 58714313; c) REF '89-10115, GTIN 50749756977901 (cs), 00749756980128 (unit), Lot Numbers: 58746278; d) REF '89-10213, GTIN 50749756350131 (cs), 00749756350136 (unit), Lot Numbers: 58745371; e) REF '89-10505, GTIN 50749756363124 (cs), 00749756363129 (unit), Lot Numbers: 58774885, 58774885; f) REF '89-10563, GTIN 50749756363988 (cs), 00749756363983 (unit), Lot Numbers: 58800174; g) REF '89-1495, GTIN 50749756214730 (cs), 00749756214735 (unit), Lot Numbers: 58762104; h) REF '89-4479, GTIN 50749756591527 (cs), 00749756591522 (unit), Lot Numbers: 58810330; i) REF '89-5424, GTIN 50749756636730 (cs), 00749756636735 (unit) Lot Numbers: 58698974; j) REF '89-6606, GTIN 50749756686421 (cs), 00749756686426 (unit) Lot Numbers: 58698907; k) REF '89-7369, GTIN 50749756736690 (cs), 00749756736695 (unit) Lot Numbers: 58777761; l) REF '89-7378, GTIN 50749756736409 (cs), 00749756736404 (unit) Lot Numbers: 58811834; m) REF '89-7540, GTIN 50749756741410 (cs), 00749756741415 (unit), Lot Numbers: 58737081; n) REF '89-8061, GTIN 50749756807291 (cs), 00749756807296 (unit), Lot Numbers: 58698042; o) REF '89-8187, GTIN 50749756818488 (cs), 00749756818483 (unit), Lot Numbers: 58736862; p) REF '89-8439, GTIN 50749756836925 (cs), 00749756836920 (unit), Lot Numbers: 58823595; q) REF '89-8445, GTIN 50749756840090 (cs), 00749756840095 (unit) Lot Numbers: 58697963; r) REF '89-8482, GTIN 50749756848331 (cs), 00749756848336 (unit), Lot Numbers: 58789411; s) REF '89-9131, GTIN 50749756945030 (cs), 00749756945035 (unit) Lot Numbers: 58808416; t) REF '89-9287, GTIN 50749756938001 (cs), 00749756938006 (unit) Lot Numbers 58789260; u) REF '89-9626, GTIN 50749756927661 (cs), 00749756927666 (unit) Lot Numbers: 58738315 v) REF '89-9632, GTIN 50749756927593 (cs), 00749756927598 (unit) Lot Numbers: 58701598
DeRoyal Industries Inc is recalling Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CA due to The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Recommended Action
Per FDA guidance
DeRoyal disseminated an URGENT! DEROYAL RECALL NOTICE to its consignees on 05/30/2023 by email. The notice explained the issue, the risk, and requested the return of the affected products. Distributors were also directed to identify and notify their customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026