MEDLINE NON-STERILE PVP SOLUTION — Class II medical device recall Z-2137-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-07-19, distributed nationwide. Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP
| Recall number | Z-2137-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-05-18 |
| Classified | 2023-07-12 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | PA |
| Quantity | 4,500 units |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 10193489236224, 10193489257946, 10193489340921, 10193489395983, 10193489735109, 10193489781502, 10193489910636, 10193489958553, 10193489996234, 10195327025694, 10195327025700, 10195327074418, 10195327097370, 10195327102029, 10195327112806, 10195327135744, 10195327135751, 10195327156985, 10195327163372, 10195327177508, 10195327190156, 10195327195366, 10195327238100, 10195327238148, 10195327239701 and 67 more |
| Lot numbers | 23BBD673, 23BBR583, 23CBH897, 23CBM408, 23CBR138, 23CBU228, 23CBV824, 23CBW640, 23CMD239, 23CMF816, 23CMG975, 23CMH862, 23DBB838, 23DBD483, 23DBE789, 23DBF769, 23DBF770, 23DBF885, 23DBH412, 23DBK433, 23DBK483, 23DBK651, 23DBM833, 23DBN415, 23DBO191, 23DBO770, 23DBP414, 23DBP964, 23DBR961, 23DBR962, 23DBS196, 23DDC201, 23DMA865, 23DME833, 23DME845, 23DMF789, 23DMG164, 23EBD808, 23EBD901, 23EBE042 and 38 more |
| Model numbers | CDS985555S, CDS985566Q, DYNJ0949139I, DYNJ24525K, DYNJ24526P, DYNJ26425L, DYNJ44635I, DYNJ50072F, DYNJ55655L, DYNJ57827D, DYNJ59126B, DYNJ60918A, DYNJ61376C, DYNJ63383, DYNJ64814A, DYNJ64951, DYNJ65093B, DYNJ65108F, DYNJ66913A, DYNJ68468C, DYNJ69153F, DYNJ80372B, DYNJ82038, DYNJ82345A, DYNJ82627A and 23 more |
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24526P; f) TOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L; g) TOTAL KNEE PACK 319735, Model Number DYNJ44635I; h) HIP ARTHROPLASTY PACK, Model Number DYNJ50072F; i) LEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L; j) TOTAL JOINT, Model Number DYNJ57827D; k) ANTERIOR HIP PACK, Model Number DYNJ59126B; l) TOTAL HIP PACK, Model Number DYNJ60918A; m) MAIN TOTAL JOINT, Model Number DYNJ61376C; n) TOTAL HIP PACK, Model Number DYNJ63383; o) ANTERIOR PACK, Model Number DYNJ64814A; p) TOTAL JOINT PACK, Model Number DYNJ64951; q) TOTAL KNEE PACK-EOSC, Model Number DYNJ65093B; r) TOTAL KNEE PACK-CSC, Model Number DYNJ65108F; s) MERCY ANTERIOR HIP, Model Number DYNJ66913A; t) TOTAL PACK, Model Number DYNJ68468C; u) TOTAL KNEE-LF, Model Number DYNJ69153F; v) TOTAL JOINT PACK, Model Number DYNJ80372B; w) ANTERIOR HIP PACK, Model Number DYNJ82038; x) HIP PACK, Model Number DYNJ82345A; y) TOTAL HIP PACK, Model Number DYNJ82627A; z) TOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553; aa) TOTAL JOINT PACK, Model Number DYNJ83567A; bb) TOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885; cc) HIP PACK, Model Number DYNJ84051; dd) TOTAL KNEE PACK, Model Number DYNJ84054; ee) OISC HAND KORCEK, Model Number DYNJ902351F; ff) TOTAL HIP, Model Number DYNJ903149D; gg) OISC TOTAL HIP BOTTROS, Model Number DYNJ904154O; hh) TOTAL HIP, Model Number DYNJ904331I; ii) TOTAL KNEE, Model Number DYNJ904332J; jj) CRANIOTOMY, Model Number DYNJ905330B; kk) TRAUMA-RAMA, Model Number DYNJ905886G; ll) ANTERIOR HIP, Model Number DYNJ907831D; mm) TOTAL HIP-LF, Model Number DYNJ908127B; nn) TOTAL KNEE-LF, Model Number DYNJ908128B; oo) TOTAL HIP CDS, Model Number DYNJ908331A; pp) TOTAL KNEE THEDA, Model Number DYNJ908683A; qq) TOTAL HIP-LF, Model Number DYNJ909000; rr) TOTAL KNEE-LF, Model Number DYNJ909002; ss) TOTAL HIP, Model Number DYNJ909198A; tt) HIP MOFFIT PPS-LF, Model Number DYNJ9428703Q; uu) LOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R; vv) UPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O
Reason for recall
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2137-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.