Recall Z-0648-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated October 9, 2024
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) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC BREAST PACK, REF DYNJ65808C; 8) OCULOPLASTY PACK, REF DYNJ81798A; 9) OPHTHO PLASTIC, REF DYNJ902256C; 10) OCULAR, REF DYNJ909065; 11) OCULAR, REF DYNJ909065A; 12) PLASTIC EYE, REF DYNJVB91043A
Codes / lots: 1) REF DYNJ27466S, UDI/DI 10195327350314 (each) 40195327350315 (case), Lot Numbers: 23DBA280; 2) REF DYNJ41207C, UDI/DI 10195327353063 (each) 40195327353064 (case), Lot Numbers: 23GMD059, 23KMH083; 3) REF DYNJ43147G, UDI/DI 10195327167257 (each) 40195327167258 (case), Lot Numbers: 22FBX412, 22FBS940; 4) REF DYNJ63329D, UDI/DI 10193489958065 (each) 40193489958066 (case), Lot Numbers: 22EBR487, 22EBC473; 5) REF DYNJ63329F, UDI/DI 10195327270414 (each) 40195327270415 (case), Lot Numbers: 23GMC980, 23LME454, 23IME156; 6) REF DYNJ64138B, UDI/DI 10193489355284 (each) 40193489355285 (case), Lot Numbers: 22FME241; 7) REF DYNJ65808C, UDI/DI 10195327369064 (each) 40195327369065 (case), Lot Numbers: 23KMF753, 23FMG930; 8) REF DYNJ81798A, UDI/DI 10195327515898 (each) 40195327515899 (case), Lot Numbers: 24CBM729, 24CBC467; 9) REF DYNJ902256C, UDI/DI 10195327089368 (each) 40195327089369 (case), Lot Numbers: 22FDA445, 22HDA810, 23CDB064, 23HDB222, 23IDB778, 23FDB836; 10) REF DYNJ909065, UDI/DI 10195327260019 (each) 40195327260010 (case), Lot Numbers: 23CMB048, 23CMA495; 11) REF DYNJ909065A, UDI/DI 10195327460648 (each) 40195327460649 (case), Lot Numbers: 24IME711, 24HME507; 12) REF…
Reason for recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
FDA-determined cause: Under Investigation by firm
Action taken
Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.
Details
- Recall number
- Z-0648-2025
- Initiated
- October 9, 2024
- Posted by FDA
- December 5, 2024
- Product code
- OJK – Eye Tray
- Quantity
- 1921 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0622-2025 Class II | MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0623-2025 Class II | MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0624-2025 Class II | MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0625-2025 Class II | MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0626-2025 Class II | MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0627-2025 Class II | MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0628-2025 Class II | MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0629-2025 Class II | MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0630-2025 Class II | MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0631-2025 Class II | MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0632-2025 Class II | MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0633-2025 Class II | MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0634-2025 Class II | MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0635-2025 Class II | Refer to RES or lead review memo for complete list of affected reference/catalog numbersMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0636-2025 Class II | MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141BMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0637-2025 Class II | MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0638-2025 Class II | MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0639-2025 Class II | MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0640-2025 Class II | MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0641-2025 Class II | MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0642-2025 Class II | MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0643-2025 Class II | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0644-2025 Class II | MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0645-2025 Class II | MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0646-2025 Class II | MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0647-2025 Class II | MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0649-2025 Class II | MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |