Z-0648-2025Class II
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3)...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-10-09 / Open, Classified / root cause: manufacturing process
MEDLINE INDUSTRIES, LP - Northfield began a recall of 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... on . FDA classified it as Class II and gives the reason as "Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0648-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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
- Product code
- OJK Eye Tray
- Reason for recall
- Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- Root cause tag
- manufacturing process
- FDA root cause
- Under Investigation by firm
- Action
- 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.
- Quantity in commerce
- 1921 units
- Distribution
- US Nationwide distribution.
- Product codes and 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 DYNJVB91043A, UDI/DI 10195327309541 (each) 40195327309542 (case), Lot Numbers: 22LDB968, 23JDC086, 23KDB345, 23FDA062, 24DDB815, 24FDB470
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0622-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0623-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0624-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0625-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0626-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0627-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0628-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0629-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0630-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0631-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0632-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0633-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0634-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0635-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0636-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0637-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0638-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0639-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0640-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0641-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0642-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0643-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0644-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0645-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0646-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0647-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0648-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0649-2025 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.