Key facts
| Recalling firm | Medline Industries, LP |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 6) TOTE SAFRAN OSC HIP ARTHRSCPY, Model Number: DYKM1767B; 7) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 8) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 9) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 10) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 11) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 12) TOTE YAO OSC WRIST ARTHROSCOPY, Model Number: DYKM1807; 13) TOTE CARROLL BLOCK BLOOD PATCH, Model Number: DYKM1864; 14) TOTE SB STONE JWIRE LUMPECTOMY/SEN NODE, Model Number: DYKM1925; 15) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 16) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977B; 17) CHEST TUBE SUPPLIES, Model Number: DYKM2131 |
| Classification | Class II |
| Recall number | Z-2102-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products. |
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Medline Industries, LP and the affected product is described in FDA's record as: Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC (additional items listed in FDA's full record). FDA's stated reason for the recall is: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2102-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome.
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC (additional items listed in FDA's full record) -- and the recall number Z-2102-2026. If it matches, stop using or distributing it and contact Medline Industries, LP or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.
Medline Industries, LP’s FDA history
Argus HQ has recorded 269 total FDA actions tied to Medline Industries, LP: 0 warning letters, 269 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- Has Medline Industries, LP had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 269 total FDA actions tied to Medline Industries, LP, including 269 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-2102-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
- Where can I verify this recall directly with FDA?
- The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
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Related enforcement actions
Full FDA history for Medline Industries, LP- Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2… →
- Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D;… →
- Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP101… →
- Recall: Medline Industries, LP — Class II recall: Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART… →
- Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A →
- Recall: Medline Industries, LP — Class II recall: Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND… →
- Recall: Medline Industries, LP — Class II recall: Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESI… →
- Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L… →
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class II Recall: Medline Convenience Kits: 1) CVC PACK, Model Number:… by Medline Industries, LP — Recall Details. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-medline-industries-lp-z-2102-2026
"FDA Class II Recall: Medline Convenience Kits: 1) CVC PACK, Model Number:… by Medline Industries, LP — Recall Details." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-medline-industries-lp-z-2102-2026.
Argus HQ Research. "FDA Class II Recall: Medline Convenience Kits: 1) CVC PACK, Model Number:… by Medline Industries, LP — Recall Details." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/recall/fda-recall-medline-industries-lp-z-2102-2026.
@misc{argushq_argushq_ai_recall_fda_recall_medline_industries_lp_z_2102_2026_2026,
title = {FDA Class II Recall: Medline Convenience Kits: 1) CVC PACK, Model Number:… by Medline Industries, LP — Recall Details},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/fda-recall-medline-industries-lp-z-2102-2026},
note = {Accessed: July 24, 2026}
}Source: FDA.gov — Recalls ↗

