MEDLINE convenience kits labeled as: 1) HEAD AND NECK — Class II medical device recall Z-0516-2026
Ongoing recall by Medline Industries, LP, reported 2025-11-26, distributed nationwide. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir
| Recall number | Z-0516-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-09-30 |
| Classified | 2025-11-14 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 3,078 kits |
| UPC / GTIN / UDI-DI | 10193489382662, 10193489437713, 10195327050092, 10195327104719, 10195327227982, 10195327297817, 10195327301835, 10195327304294, 10195327352493, 10195327375003, 10195327375010, 10195327412081, 10195327466428, 10195327512033, 10195327528218, 10195327587581, 10195327587604, 10195327647827, 10195327689841, 10195327698089, 40193489382663, 40193489437714, 40195327050093, 40195327104710, 40195327227983 and 15 more |
| Lot numbers | 23EBK256, 23EDB639, 23FBR754, 23FDA156, 23FDA196, 23FDA246, 23FMB928, 23GBB195, 23GBH766, 23GBN444, 23GBN735, 23GBT502, 23GDA649, 23GDA674, 23GMI073, 23HBM886, 23HDA365, 23HLB079, 23HMC691, 23IBP461, 23IBU467, 23ILA192, 23JBR528, 23JMC414, 23JMD230, 23JMD840, 23LMA073, 23LME135, 23LMH745, 24ABD023, 24ABP608, 24ABX584, 24ADB523, 24ALA650, 24ALB133, 24AMB618, 24BBN514, 24BME178, 24DBA020, 24DBQ755 and 7 more |
| Model numbers | CDS984259O, CDS984259P, DYNJ0160700F, DYNJ0161710I, DYNJ0161795F, DYNJ0429404O, DYNJ0429404P, DYNJ0429430S, DYNJ27320V, DYNJ55235C, DYNJ64235B, DYNJ65020C, DYNJ67754B, DYNJ68211B, DYNJ68957B, DYNJ902331D, DYNJ906655G, DYNJ907577, DYNJ9425991Q, DYNJVB91072A |
Product
MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P; 8) THYROID MOFF PACK-LF, REF DYNJ0429430S; 9) NASALPLASTY #61-RF, REF DYNJ27320V; 10) MIDDLE EAR PACK, REF DYNJ55235C; 11) HEAD AND NECK, REF DYNJ64235B; 12) NECK PACK SRM-LF, REF DYNJ65020C; 13) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 14) ENT HEAD NECK PACK, REF DYNJ68211B; 15) OSC ENT HEAD PACK, REF DYNJ68957B; 16) EAR UM-LF, REF DYNJ902331D; 17) HEAD&NECK, REF DYNJ906655G; 18) ENT-LF, REF DYNJ907577; 19) MAJOR HEAD AND NECK PPS, REF DYNJ9425991Q; 20) MINOR ENT # 56653-LF, REF DYNJVB91072A.
Reason for recall
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
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-0516-2026. 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.