| | Class 1 Device Recall MEDLINE CSECTION |  |
| Date Initiated by Firm | June 05, 2026 |
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| Date Posted | July 22, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2749-2026 |
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| Recall Event ID |
99290 |
| 510(K)Number | K213481 |
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| Product Classification |
Orthopedic tray - Product Code OJH
|
| Product | MEDLINE convenience kits labeled as:
1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A;
2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J;
3) TOTAL HIP, Medline Kit SKU DYNJ903492K;
4) ANTERIOR HIP, Medline Kit SKU DYNJ903493I;
5) ANTERIOR HIP, Medline Kit SKU DYNJ903493J;
6) ANTERIOR HIP, Medline Kit SKU DYNJ903493K;
7) TOTAL HIP, Medline Kit SKU DYNJ906665G;
8) TOTAL KNEE, Medline Kit SKU DYNJ906666J;
9) TOTAL HIP-LF, Medline Kit SKU DYNJ909000A;
10) TOTAL KNEE-LF, Medline Kit SKU DYNJ909002A;
11) TOTAL HIP W NAVIGATION NO SYR, Medline Kit SKU DYNJ909068B;
12) TOTAL JOINT, Medline Kit SKU DYNJ909069B;
13) TOTAL KNEE, Medline Kit SKU DYNJ909070C;
14) TOTAL KNEE W NAVIGATION NO SYR, Medline Kit SKU DYNJ909071B;
15) TOTAL KNEE W NAVIGATION, Medline Kit SKU DYNJ909071C;
16) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534;
17) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534A;
18) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534B;
19) ANTERIOR HIP, Medline Kit SKU DYNJ909640F;
20) POSTERIOR HIP, Medline Kit SKU DYNJ909642D;
21) TOTAL KNEE, Medline Kit SKU DYNJ909643D;
22) TOTAL KNEE, Medline Kit SKU DYNJ909643F;
23) TOTAL JOINT, Medline Kit SKU DYNJ910002A;
24) TOTAL KNEE, Medline Kit SKU DYNJ910354A;
25) TOTAL HIP, Medline Kit SKU DYNJ910813;
26) ANTERIOR HIP, Medline Kit SKU DYNJ911083. |
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| Code Information |
Medline Kit SKU DYKS1574A, UDI/DI 10198459147449 (each) 40198459147440 (case), Kit Lot Number 25ELB079;
Medline Kit SKU DYKS1574A, UDI/DI 10198459147449 (each) 40198459147440 (case), Kit Lot Number 25DLA930;
Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25IBN992;
Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25HBS205;
Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25DBH984;
Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25CBB436;
Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25ABR220;
Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 24LBI991;
Medline Kit SKU DYNJ903492K, UDI/DI 10198459255199 (each) 40198459255190 (case), Kit Lot Number 25CBR847;
Medline Kit SKU DYNJ903492K, UDI/DI 10198459255199 (each) 40198459255190 (case), Kit Lot Number 25CBE741;
Medline Kit SKU DYNJ903493I, UDI/DI 10195327565510 (each) 40195327565511 (case), Kit Lot Number 25ADA380;
Medline Kit SKU DYNJ903493I, UDI/DI 10195327565510 (each) 40195327565511 (case), Kit Lot Number 24KDA993;
Medline Kit SKU DYNJ903493J, UDI/DI 10198459255052 (each) 40198459255053 (case), Kit Lot Number 25CDA748;
Medline Kit SKU DYNJ903493J, UDI/DI 10198459255052 (each) 40198459255053 (case), Kit Lot Number 25CDA157;
Medline Kit SKU DYNJ903493K, UDI/DI 10198459293122 (each) 40198459293123 (case), Kit Lot Number 25DDA444;
Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25GDA109;
Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25FDB471;
Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25EDB817;
Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25BDA465;
Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24LDB209;
Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24LDA032;
Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24KDB063;
Medline Kit SKU DYNJ906666J, UDI/DI 10195327129590 (each) 40195327129591 (case), Kit Lot Number 25ABU735;
Medline Kit SKU DYNJ906666J, UDI/DI 10195327129590 (each) 40195327129591 (case), Kit Lot Number 24LBU076;
Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25EBN666;
Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25DBF470;
Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25CBA048;
Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25FBH718;
Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25EBF688;
Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25DBO198;
Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25ABL694;
Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 24KBU683;
Medline Kit SKU DYNJ909068B, UDI/DI 10198459077364 (each) 40198459077365 (case), Kit Lot Number 25ABI346;
Medline Kit SKU DYNJ909068B, UDI/DI 10198459077364 (each) 40198459077365 (case), Kit Lot Number 24LBR150;
Medline Kit SKU DYNJ909068B, UDI/DI 10198459077364 (each) 40198459077365 (case), Kit Lot Number 24LBD242;
Medline Kit SKU DYNJ909069B, UDI/DI 10198459248375 (each) 40198459248376 (case), Kit Lot Number 25EBM976;
Medline Kit SKU DYNJ909069B, UDI/DI 10198459248375 (each) 40198459248376 (case), Kit Lot Number 25CBJ024;
Medline Kit SKU DYNJ909069B, UDI/DI 10198459248375 (each) 40198459248376 (case), Kit Lot Number 25BBA740;
Medline Kit SKU DYNJ909070C, UDI/DI 10198459257490 (each) 40198459257491 (case), Kit Lot Number 25EBQ769;
Medline Kit SKU DYNJ909070C, UDI/DI 10198459257490 (each) 40198459257491 (case), Kit Lot Number 25CBU372;
Medline Kit SKU DYNJ909071B, UDI/DI 10198459139321 (each) 40198459139322 (case), Kit Lot Number 25ABF133;
Medline Kit SKU DYNJ909071B, UDI/DI 10198459139321 (each) 40198459139322 (case), Kit Lot Number 24LBD821;
Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25FBA422;
Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25DBS695;
Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25CBV173;
Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25CBG902;
Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25BBN621;
Medline Kit SKU DYNJ909534, UDI/DI 10195327389147 (each) 40195327389148 (case), Kit Lot Number 25ABV657;
Medline Kit SKU DYNJ909534, UDI/DI 10195327389147 (each) 40195327389148 (case), Kit Lot Number 24LBO734;
Medline Kit SKU DYNJ909534, UDI/DI 10195327389147 (each) 40195327389148 (case), Kit Lot Number 24LBO776;
Medline Kit SKU DYNJ909534A, UDI/DI 10198459273209 (each) 40198459273200 (case), Kit Lot Number 25CBF686;
Medline Kit SKU DYNJ909534B, UDI/DI 10198459527814 (each) 40198459527815 (case), Kit Lot Number 25JBN131;
Medline Kit SKU DYNJ909640F, UDI/DI 10198459250057 (each) 40198459250058 (case), Kit Lot Number 25DBD310;
Medline Kit SKU DYNJ909642D, UDI/DI 10198459250040 (each) 40198459250041 (case), Kit Lot Number 25HBR652;
Medline Kit SKU DYNJ909643D, UDI/DI 10198459250064 (each) 40198459250065 (case), Kit Lot Number 25DBB386;
Medline Kit SKU DYNJ909643F, UDI/DI 10198459392603 (each) 40198459392604 (case), Kit Lot Number 25HBU964;
Medline Kit SKU DYNJ910002A, UDI/DI 10198459073335 (each) 40198459073336 (case), Kit Lot Number 25DBH861;
Medline Kit SKU DYNJ910354A, UDI/DI 10198459089282 (each) 40198459089283 (case), Kit Lot Number 25DBF544;
Medline Kit SKU DYNJ910354A, UDI/DI 10198459089282 (each) 40198459089283 (case), Kit Lot Number 25CBM051;
Medline Kit SKU DYNJ910813, UDI/DI 10198459123276 (each) 40198459123277 (case), Kit Lot Number 25CBU686;
Medline Kit SKU DYNJ910813, UDI/DI 10198459123276 (each) 40198459123277 (case), Kit Lot Number 25CBF765;
Medline Kit SKU DYNJ911083, UDI/DI 10198459242335 (each) 40198459242336 (case), Kit Lot Number 25DBK837;
Medline Kit SKU DYNJ911083, UDI/DI 10198459242335 (each) 40198459242336 (case), Kit Lot Number 25CBN099. |
| FEI Number |
1417592
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Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer Reason
for Recall | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/5/2026 via USPS and email. The notice explained the issue, potential risk to health, and requested the following: identify and quarantine product, and complete response and return the response form using the Website link: https://recalls.medline.com. Those who further distributed the affected product have been directed to notify their customers. Upon receipt of the submitted response form, the consignee will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.
For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
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| Quantity in Commerce | 2301 kits |
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| Distribution | US: OH, CA, IL, IN, FL, SC, AZ, NJ.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = OJH
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