Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 63,320 units distributed worldwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential sterile barrier breach, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrode Retractable (Item Code: E2783R28ASP) due to a potential compromise of the package that could result in a breach of the sterile barrier. The recall affects 63,320 units with lot numbers ranging from 209284X through 60870084X.
These devices are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation, and suction via a single handset is desirable. The affected units were distributed nationwide in the United States and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand.
The FDA has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but the recall is driven by the risk of the sterile barrier being breached.
The recalled product
- Product
- Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction…
- Manufacturer
- Medtronic
- Hazard
- Affected units
- 63,320
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 (1)
- Affected Lot Range: 209284X through 60870084X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Medtronic 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 25 products in this recall →Related recalls
Same manufacturer · Medtronic
See all →- HighMedtronic Recalls USPACK Suture Kits Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
- HighMedtronic Recalls Best Practice Kits Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
- HighMedtronic Recalls Pacemaker Angio X3 Due to Potential Seal Defect
FDA (Devices) · 2017-06-21
- ModerateMedtronic Recalls Polysorb Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
- SevereMedtronic Recalls Custom Suture Packs Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
Same hazard · sterile barrier breach
See all →- ModerateBoston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
FDA (Devices) · 2026-08-12
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
Similar recalls
- HighValleylab Laparoscopic Handset Recalled for Activation Button Failure
FDA (Devices) · 2017-04-26
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- HighMedtronic Intact Disposable Wands Recalled for Sterility Compromise
FDA (Devices) · 2017-02-08
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27