Medline custom medical procedure kits labeled as: 1) CRANI — Class II medical device recall Z-0794-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-01-08, distributed nationwide. Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical St
| Recall number | Z-0794-2025 |
|---|---|
| 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 | 2024-11-21 |
| Classified | 2024-12-30 |
| Reported by FDA | 2025-01-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA |
| Quantity | 474,300 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10080196778942, 10193489200751, 10193489201383, 10193489201949, 10193489202557, 10193489203202, 10193489205237, 10193489205541, 10193489205602, 10193489205794, 10193489212884, 10193489213904, 10193489216929, 10193489217629, 10193489218114, 10193489219746, 10193489228458, 10193489230611, 10193489230673, 10193489230970, 10193489236262, 10193489236606, 10193489236736, 10193489237665, 10193489237740 and 475 more |
| Lot numbers | 18LBO391, 18LBO679, 18LBP617, 18LBP746, 18LBP748, 18LBQ212, 18LDC142, 18LDC999, 18LKC904, 19ABA312, 19ABA345, 19ABA354, 19ABA978, 19ABA990, 19ABB743, 19ABB875, 19ABC034, 19ABC102, 19ABC328, 19ABC362, 19ABC997, 19ABD408, 19ABE811, 19ABF907, 19ABF957, 19ABG041, 19ABG995, 19ABH677, 19ABH849, 19ABH870, 19ABH953, 19ABI412, 19ABI867, 19ABK067, 19ABK254, 19ABL742, 19ABM220, 19ABM320, 19ABM941, 19ABM968 and 460 more |
| Model numbers | 37AA, CDS780089V, CDS780102K, CDS780102L, CDS780102M, CDS780105K, CDS780105L, CDS780105M, CDS780119V, CDS780166Q, CDS780205O, CDS780205P, CDS780205Q, CDS780206O, CDS780206P, CDS780206R, CDS780208I, CDS780214M, CDS780214N, CDS940087AL, CDS940875P, CDS98, CDS980929Q, CDS980929R, CDS980929S and 475 more |
Product
Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRANIOTOMY CDS-LF, REF CDS780105K; 6) CRANIOTOMY CDS-LF, REF CDS780105L; 7) CRANIOTOMY CDS-LF, REF CDS780105M; 8) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 9) CRANIOTOMY CDS, REF CDS780166Q; 10) ANTERIOR CERVICAL CDS, REF CDS780205O; 11) ANTERIOR CERVICAL CDS, REF CDS780205P; 12) ANTERIOR CERVICAL CDS, REF CDS780205Q; 13) CRANIOTOMY CDS, REF CDS780206O; 14) CRANIOTOMY CDS, REF CDS780206P; 15) CRANIOTOMY CDS, REF CDS780206R; 16) NEURO-LAMI CDS, REF CDS780208I; 17) SHY CRANIOTOMY CDS, REF CDS780214M; 18) SHY CRANIOTOMY CDS, REF CDS780214N; 19) SPINAL CDS, REF CDS940087AL; 20) ORTHO SPINE PROCEDURE, REF CDS940875P; 21) CRANIOTOMY-RICHMOND, REF CDS980929Q; 22) CRANIOTOMY-RICHMOND, REF CDS980929R; 23) CRANIOTOMY-RICHMOND, REF CDS980929S; 24) CRANIOTOMY-RICHMOND, REF CDS980929T; 25) CRANIOTOMY-RICHMOND, REF CDS980929U; 26) OMC LUMBAR CDS, REF CDS981062I; 27) LAMINECTOMY CDS, REF CDS981229A; 28) ORTHO SPINE SUPPLEMENTAL CDS, REF CDS981742M; 29) CRANIOTOMY CDS, REF CDS981888X; 30) ANTERIOR CERVICAL DISC, REF CDS982023S; 31) ANTERIOR CERVICAL DISC, REF CDS982023T; 32) CRANIOTOMY, REF CDS982029R; 33) CRANIOTOMY, REF CDS982029S; 34) LAMI FUSION, REF CDS982035T; 35) LAMI FUSION, REF CDS982035U; 36) MICRODISCECTOMY, REF CDS982054W; 37) CRANIOTOMY CDS, REF CDS982480L; 38) CRANIOTOMY CDS, REF CDS982480M; 39) CRANIOTOMY CDS, REF CDS982480N; 40) CRANIOTOMY CDS, REF CDS982480O; 41) CRANIOTOMY CDS, REF CDS982480P; 42) LAMINECTOMY CDS, REF CDS982491L; 43) LAMINECTOMY CDS, REF CDS982491M; 44) LAMINECTOMY CDS, REF CDS982491N; 45) LAMINECTOMY CDS, REF CDS982491O; 46) LAMINECTOMY CDS, REF CDS982491P; 47) LAMINECTOMY CDS, REF CDS982491Q; 48) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563C; 49) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563D; 50) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563F; 51) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563G; 52) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563I; 53) NEURO SPINE CDS, REF CDS982683O; 54) NEURO SPINE CDS, REF CDS982683P; 55) NEURO SPINE CDS, REF CDS982683R; 56) NEURO SPINE CDS, REF CDS982683S; 57) NEURO SPINE CDS, REF CDS982683U; 58) NEURO SPINE CDS, REF CDS982683V; 59) NEURO SPINE, REF CDS982683W; 60) CRANIOTOMY, REF CDS982719P; 61) CRANIOTOMY, REF CDS982719Q; 62) CRANIOTOMY, REF CDS982719R; 63) CRANIOTOMY, REF CDS982719S; 64) CRANIOTOMY, REF CDS982719T; 65) CRANIOTOMY, REF CDS982719U; 66) CRANIOTOMY, REF CDS982719V; 67) CRANIOTOMY, REF CDS982719W; 68) ORTHO SPINE, REF CDS982735M; 69) ORTHO SPINE, REF CDS982735N; 70) ORTHO SPINE, REF CDS982735O; 71) ORTHO SPINE, REF CDS982735Q; 72) ORTHO SPINE, REF CDS982735R; 73) ORTHO SPINE, REF CDS982735S; 74) ORTHO SPINE, REF CDS982735U; 75) SPINAL CDS, REF CDS983037J; 76) SPINAL CDS, REF CDS983037K; 77) CRANIOTOMY CDS, REF CDS983094D; 78) CERVICAL SPINE CDS, REF CDS983108F; 79) LAMINECTOMY CDS, REF CDS983115F; 80) ZALE SPINE CDS, REF CDS983182F; 81) ZALE SPINE CDS, REF CDS983182G; 82) ZALE SPINE CDS, REF CDS983182I; 83) ZALE SPINE CDS, REF CDS983182J; 84) ZALE SPINE CDS, REF CDS983182K; 85) ZALE SPINE CDS, REF CDS983182L; 86) ZALE SPINE CDS, REF CDS983182M; 87) ZALE CRANIOTOMY CDS, REF CDS983188F; 88) ZALE CRANIOTOMY CDS, REF CDS983188K; 89) CRANIOTOMY, REF CDS983349J; 90) CRANIOTOMY, REF CDS983349K; 91) CRANIOTOMY, REF CDS983349L; 92) CRANIOTOMY, REF CDS983349M; 93) CRANIOTOMY, REF CDS983349N; 94) CRANIOTOMY, REF CDS983349O; 95) CRANI CDS, REF CDS983386G; 96) CRANIOTOMY CDS, REF CDS983467D; 97) CRANIOTOMY CDS, REF CDS983467F; 98) CRANIOTOMY CDS, REF CDS983467G; 99) CRANIOTOMY CDS, REF CDS983467I; 100) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476D; 101) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476F; 102) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476G; 103) LUMBAR LAMINECTOMY NEURO CDS, REF CDS98
Reason for recall
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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-0794-2025. 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.