Quick Facts at a Glance
- Recall Date
- December 16, 2025
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medline Industries, LP
- Product type
- Medical Procedure Convenience Kits
- Model numbers
- REF CDS980523M: UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25FBF036, Lot number 25DBB218, REF CDS980647K: UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25DBP829, Lot number 25CBI860, REF CDS980864Q: UDI/DI 10198459121937 (EA) 40198459121938 (CS), Lot number 25EMC533 +8 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 16, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
About This Product
Medline medical procedure convenience kits are utilized in various surgical procedures to provide necessary tools and supplies. These kits are crucial for healthcare providers to ensure that they have everything required for specific medical interventions.
Why This Is Dangerous
The design change in the Strykeflow 2 Suction Irrigator allows saline solution to leak into the device's handpiece and battery pack, leading to potential burn risks from vaporized saline emissions, which can look like smoke.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses an immediate risk to patient safety, requiring healthcare providers to halt use of the kits, which could disrupt medical procedures and operations.
Practical Guidance
How to identify if yours is affected
- Check the reference number on your medical kit against the recalled list.
- Look for any lot numbers mentioned in the recall details.
- Contact the manufacturer if unsure about your product's status.
Where to find product info
Reference numbers and lot numbers can typically be found on the packaging or product label of the kits.
What timeline to expect
Expect a refund within 4-6 weeks after returning the recalled product.
If the manufacturer is unresponsive
- Follow up with Medline Industries through their customer service line.
- Document your communication attempts for your records.
- Consider filing a complaint with the FDA if necessary.
How to prevent similar issues
- When purchasing medical devices, verify that they have not been subject to recent recalls.
- Check for safety certifications and read user reviews regarding reliability.
- Stay informed about product updates from manufacturers.
Documentation advice
Keep all correspondence with the manufacturer and any receipts or transaction records related to the purchase.
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Product Details
The recall affects 12,584 medical procedure convenience kits, including multiple reference numbers. These kits were distributed nationwide in the United States and were available through various healthcare providers.
Key Facts
- Recall date: December 16, 2025
- Total kits recalled: 12,584
- No injuries or deaths reported
- High hazard classification
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Safety Guide
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