Procedure kits recalled over suction irrigators that can leak during use
Medline is recalling 4,536 procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites leakage and vapour emission from a kit component with no stated patient harm or reported injury.
Plain-English summary
Medline medical procedure convenience kits are being recalled, covering the WCH Bari-Gastrectomy CDS (REF CDS860237AF), Robotic Procedure (CDS982128Q), CUH Thoracic (CDS984338M), Thoracic Procedure (CDS984640I) and DaVinci Robotic Pack-LF among the kits listed in the enforcement record.
The kits contain Stryker's Strykeflow 2 Suction Irrigators. The record states that 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, and that this design change has caused some devices to leak and/or emit vaporized saline, which can resemble smoke, during use.
The record lists 4,536 units, with REF numbers, UDI/DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The record describes leakage and vapour emission and states no further consequence or reported injuries. Facilities should quarantine affected kits and follow Medline's instructions.
The recalled product
- Product
- Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable…
- Manufacturer
- Heraeus Medical GmbH (Dental Division)
- Category
- Medical Device — Procedure kit
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code: UDI-DI: 04260102135338
- 04260102135369
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Heraeus Medical GmbH (Dental Division) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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