Recall archive / FDA device enforcement
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ6... — FDA record Z-1646-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 21, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.
- Reason
- The kits were damaged by water.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 342 packs (114 packs/product)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1646-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | (1) Arthroscopy Pack - Lot #22HMD098, Exp. 2024-04-30, UDI/DI (01)10193489956405; (2) Shoulder Pack -Lot #22JMA673, Exp. 2024-01-31, GTIN (01)10193489429817; and (3) Upper Extremity Pack - Lot #HMF900, Exp. 2024-01-31, UDI/DI (01)10193489968453. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution was made to California. There was no foreign/government/military distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 7, 2023
- Recall initiation date
- Apr 21, 2023
- Center classification date
- May 26, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.