Hysterectomy procedure kits recalled over leaking suction irrigators inside
Medline is recalling 1457 units of 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 by Medline Industries, LP, covering LAVH Procedure (REF CDS980754T), GYN Lap Hysterectomy CDS (CDS982662Q), DaVinci Hysterectomy CDS (CDS985344F), LAVH (DYNJQ9041R) and Laparoscopic Hysterectomy 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 1457 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
- Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 1,457
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 (20)
- REF CDS980754T: UDI/DI 10198459121814 (EA) 40198459121815 (CS)
- Lot Number 25EMD795
- REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS)
- Lot Number 25EBR237
- Lot Number 25EBP591
- Lot Number 25DBM353
- Lot Number 25CBL184
- Lot Number 25BBL633
- REF CDS985344F: UDI/DI 10195327312565 (EA) 40195327312566 (CS)
- Lot Number 25FBK918
- Lot Number 25CBJ496
- REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS)
- Lot Number 25FBF371
- Lot Number 25EBK493
- Lot Number 25DBH895
- REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS)
- Lot Number 25DBC272
- Lot Number 25CBU642
- Lot Number 25CBJ298
- Lot Number 25BBU206
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Medline Industries, LP 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.
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