Recall Z-0516-2026
Medline Industries, LP · initiated September 30, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 1) REF CDS984259O: UDI/DI 10195327297817 (each), 40195327297818 (case), Lot Numbers: 23FBR754, 23GBH766, 24ABP608, 24BBN514; 2) REF CDS984259P: UDI/DI 10195327647827 (each), 40195327647828 (case), Lot Numbers: 24DBQ755; 3) REF DYNJ0160700F: UDI/DI 10195327304294 (each), 40195327304295 (case), Lot Numbers: 23FDA156, 23GDA649; 4) REF DYNJ0161710I: UDI/DI 10195327375003 (each), 40195327375004 (case), Lot Numbers: 23EDB639, 23FDA196, 23GDA674; 5) REF DYNJ0161795F: UDI/DI 10195327375010 (each), 40195327375011 (case), Lot Numbers: 23FDA246, 23HDA365; 6) REF DYNJ0429404O: UDI/DI 10195327050092 (each), 40195327050093 (case), Lot Numbers: 23GMI073, 23JMC414, 23LMA073; 7) REF DYNJ0429404P: UDI/DI 10195327587581 (each), 40195327587582 (case), Lot Numbers: 23LMH745, 24BME178, 24DMF230; 8) REF DYNJ0429430S: UDI/DI 10195327689841 (each), 40195327689842 (case), Lot Numbers: 24LME516; 9) REF DYNJ27320V: UDI/DI 10195327104719 (each), 40195327104710 (case), Lot Numbers: 23GBT502, 24ABD023, 24ABX584, 24DBA020, 24DBU467, 24FBD739; 10) REF DYNJ55235C: UDI/DI 10195327412081 (each), 40195327412082 (case), Lot Numbers: 23GBN444, 23IBU467; 11) REF DYNJ64235B: UDI/DI 10193489382662 (each), 40193489382663…
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.
FDA-determined cause: Under Investigation by firm
Action taken
Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/30/2025 and 10/6/2025 via email and mail. The notice explained the issue with the component, potential risk, and requested the following actions: 1. Immediately check stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information found in the notice to complete the response form. Please list the quantity of affected product in inventory on the form. Even if no affected product is in inventory, please complete and submit the form. 3. Upon receipt of the submitted response form, the customer account will receive over-labels to place on affected inventory, with instructions for the customer staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. For distributors or those who have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-0516-2026
- Initiated
- September 30, 2025
- Posted by FDA
- November 14, 2025
- Product code
- OGR – Ear, Nose, And Throat Surgical Tray
- Quantity
- 3078 kits
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0511-2026 Class II | MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418MMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0512-2026 Class II | MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818AMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0513-2026 Class II | MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0514-2026 Class II | MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0515-2026 Class II | MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2)…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0517-2026 Class II | MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0518-2026 Class II | MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0519-2026 Class II | MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2)…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0520-2026 Class II | MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2)…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0521-2026 Class II | MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0522-2026 Class II | MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0523-2026 Class II | MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0524-2026 Class II | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2)…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0525-2026 Class II | MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826OMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0526-2026 Class II | MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2)…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0527-2026 Class II | MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0528-2026 Class II | MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004FMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0529-2026 Class II | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |
| Z-0530-2026 Class II | MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2)…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | 09/30/2025Open, Classified |