Severity
Critical
FDA Devices recall · Reported March 6, 2024
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Steril…
Medline Industries, LP - Northfield recalled Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; … - a critical-severity action.
Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; … was recalled by Medline Industries, LP - Northfield in March 6, 2024. Reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurs…. Check the official notice for the remedy. Verify recall #Z-1127-2024 with the FDA Devices before acting.
The recall
Medline Industries, LP - Northfield issued this critical-severity FDA Devices recall — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurs….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1127-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1127-2024) was formally reported on March 6, 2024, with the manufacturer initiating the action on November 15, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Medline Industries, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 14280 units.
The documented reason for this recall is: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Fl… Distribution data in the federal record shows the product reached: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category — 40,409 medical devices recalls on record
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Critical
Affected scope
14280 units
Related Recalls
6
6 from same agency
Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1629; c) CVL INSERTION KIT-LF, REF DYNJ48587A; d) EXTREMITY CDS, REF CDS983313I; e) EXTREMITY CDS, REF DYNJ902004D; f) EXTREMITY CDS, REF DYNJ902004F; g) EXTREMITY IV, REF CMPJ06040D; h) EXTREMITY IV, REF CMPJ06040F; i) EXTREMITY PROCEDURE, REF CDS981656I; j) FACIAL PLASTY PACK, REF DYNJ55335D; k) FOOT PROCEDURE, REF CDS981659I; l) FOOT PROCEDURE, REF CDS981659J; m) HAND, REF DYNJ902002J; n) HAND PACK, REF DYNJ35744A; o) HAND PACK, REF DYNJ68873C; p) HAND PACK, REF DYNJ46211K; q) KNEE ARTHROSCOPY CDS, REF CDS941004C; r) KNEE PACK, REF DYNJ68512; s) LACERATION TRAY, REF SUT21580; t) LOWER EXTREMITY, REF DYNJ907121F; u) LOWER EXTREMITY, REF DYNJ46222M; v) LOWER EXTREMITY PACK, REF DYNJ67216C; w) LOWER EXTREMITY PACK, REF DYNJ67216D; x) PACK,POSTERIOR SPINAL FUSION, REF DYNJ906892; y) PODIATRY PACK, REF DYNJ68347A; z) PODIATRY PACK, REF DYNJ68347B; aa) PODIATRY PACK-LF, REF DYNJ34648D; bb) POSTERIOR PACK, REF DYNJ64576A; cc) SHOULDER, REF DYNJ903011J; dd) SHOULDER ARTHROTOMY PROCEDURE, REF CDS981658G; ee) SHOULDER KIT, REF DYNJ907705D; ff) SMALL HAND CDS, REF DYNJ902002G; gg) SMALL HAND CDS, REF DYNJ902002I; hh) SMALL HAND PACK, REF CMPJ06038F; ii) SMALL HAND PACK, REF CMPJ06038G; jj) TOTAL KNEE, REF DYNJ909159; kk) TOTAL KNEE CDS, REF CDS982823P; ll) TOTAL KNEE CDS, REF CDS982823Q; mm) TRIGGER FINGER KIT, REF DYNJ68406; nn) UPPER EXTREMITY, REF DYNJ907130C
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1127-2024 |
| Date reported | March 6, 2024 |
| Date initiated | November 15, 2023 |
| Recalling firm | Medline Industries, LP - Northfield |
| Firm location | Northfield, IL |
| Affected scope | 14280 units |
| Distribution | Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
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This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 6, 2024.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.