Recall archive / FDA device enforcement
Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYN... — FDA record Z-2750-2024
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 8, 2024. 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
- Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179A; 5) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179AH; 6) JSI-MUSCLE&PLASTICS PACK-LF , Pack Number DYNJ0608555P; 7) OCCULAR PLASTIC, Pack Number DYNJ901206F; 8) OCCULAR PLASTIC PACK, Pack Number CMPJ05506F; 9) OCCULOPLASTIC PACK, Pack Number DYNJ65156; 10) PLASTIC PACK, Pack Number DYNJ47842C;
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2750-2024
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 | DYKM2000 , Lot Number: 21FBO406 DYKM2000 , Lot Number: 22DBI980 DYKM2000 , Lot Number: 22KBD028 DYKM2000 , Lot Number: 23JBC148 DYKM2000 , Lot Number: 24ABL480 DYKM2000 , Lot Number: 21ABM981 DYKM2000 , Lot Number: 21BBR866 DYNJ902703K, Lot Number: 21FBI191 DYNJ902703K, Lot Number: 21FBR340 DYNJ902703K, Lot Number: 22OBL867 DYNJ902703K, Lot Number: 22DBH342 DYNJ902703K, Lot Number: 22DBI420 DYNJ902703K, Lot Number: 22FBM439 DYNJ38988J , Lot Number: 23JDA299 DYNJ82179A , Lot Number: 23JDB728 DYNJ82179AH, Lot Number: 23JDB728 DYNJ0608555P , Lot Number: 23GMI735 DYNJ0608555P , Lot Number: 23KMC310 DYNJ901206F, Lot Number: 23IBC085 DYNJ901206F, Lot Number: 23LBA443 DYNJ901206F, Lot Number: 24ABY049 CMPJ05506F , Lot Number: 23HBM696 CMPJ05506F , Lot Number: 23KBK942 CMPJ05506F , Lot Number: 24ABM251 DYNJ65156, Lot Number: 21GDC910 DYNJ65156, Lot Number: 21JDA096 DYNJ65156, Lot Number: 22CDC307 DYNJ65156, Lot Number: 23BDC115 DYNJ65156, Lot Number: 23EDC523 DYNJ65156, Lot Number: 23GDA856 DYNJ47842C , Lot Number: 23HBV422 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 4, 2024
- Recall initiation date
- Apr 8, 2024
- Center classification date
- Aug 28, 2024
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.