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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74602

25 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 08, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

25 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 25

Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 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 via a single handset is desirable

Z-2554-2016
Recall number
Z-2554-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
13420

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 210141X through 61220104X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 2 of 25

Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 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 via a single handset is desirable

Z-2555-2016
Recall number
Z-2555-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
19200

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 210286X through 61220102X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 3 of 25

Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: E25306 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 via a single handset is desirable

Z-2556-2016
Recall number
Z-2556-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
19200

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 210286X through 61220102X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 4 of 25

Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258028 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 via a single handset is desirable

Z-2557-2016
Recall number
Z-2557-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
6769

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 210573X through 60870080X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 5 of 25

Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 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 via a single handset is desirable

Z-2558-2016
Recall number
Z-2558-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
3530

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 211742X through 60870082X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 6 of 25

Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 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 via a single handset is desirable

Z-2559-2016
Recall number
Z-2559-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
210

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 216416X through 60080002X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 7 of 25

Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E258328 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 via a single handset is desirable

Z-2560-2016
Recall number
Z-2560-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
2920

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 210556X through 60520063X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 8 of 25

Valleylab Laparoscopic Straight Spatula Electrode 36C Item Code: E277036 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 via a single handset is desirable

Z-2561-2016
Recall number
Z-2561-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
13516

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 215084X through 61220127X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 9 of 25

Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 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 via a single handset is desirable

Z-2562-2016
Recall number
Z-2562-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
161940

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 210654X through 61380120X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 10 of 25

Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 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 via a single handset is desirable

Z-2563-2016
Recall number
Z-2563-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
6381

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 209505X through 61220130X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 11 of 25

Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 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 via a single handset is desirable

Z-2564-2016
Recall number
Z-2564-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
85630

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 210110X through 61250197X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 12 of 25

Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 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 via a single handset is desirable

Z-2565-2016
Recall number
Z-2565-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
349629

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 00378X through 61220135X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 13 of 25

Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 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 via a single handset is desirable

Z-2566-2016
Recall number
Z-2566-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
24870

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 210409X through 61220133X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 14 of 25

Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 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 via a single handset is desirable

Z-2567-2016
Recall number
Z-2567-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
119770

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 210652X through 61390114X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 15 of 25

Valleylab Laparoscopic Straight Spatula Electrode 28CM Item Code: E278028 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 via a single handset is desirable

Z-2568-2016
Recall number
Z-2568-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
6720

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 212060X through 60520072X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 16 of 25

Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 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 via a single handset is desirable

Z-2569-2016
Recall number
Z-2569-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 209716X through 61220115X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 17 of 25

Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code: E2781R28ASP 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 via a single handset is desirable

Z-2570-2016
Recall number
Z-2570-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 209358X through 60870083X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 18 of 25

Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 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 via a single handset is desirable

Z-2571-2016
Recall number
Z-2571-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 209822X through 61220117X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 19 of 25

Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP 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 via a single handset is desirable

Z-2572-2016
Recall number
Z-2572-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
1440

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 213559X through 60520066X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 20 of 25

Valleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328 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 via a single handset is desirable

Z-2573-2016
Recall number
Z-2573-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
42900

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 209965X through 60870090X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 21 of 25

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 via a single handset is desirable

Z-2574-2016
Recall number
Z-2574-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
63320

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 209284X through 60870084X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 22 of 25

Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP 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 via a single handset is desirable

Z-2575-2016
Recall number
Z-2575-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
50055

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 208908X through 61220113X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 23 of 25

Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 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 via a single handset is desirable

Z-2576-2016
Recall number
Z-2576-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
332

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 209220X through 52140033X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 24 of 25

Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP 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 via a single handset is desirable

Z-2577-2016
Recall number
Z-2577-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
3470

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 209503X through 60870086X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

device · product 25 of 25

Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code: E278628 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 via a single handset is desirable

Z-2578-2016
Recall number
Z-2578-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Code information

Affected Lot Range: 213786X through 61220121X

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,