FDA (Devices) recall action 74602

Medtronic recalled 25 products on 2016-08-24

The FDA (Devices) publishes a recall like this one as 25 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 25 pages.

Products: 25
Announced: 2016-08-24
Critical: 0
Units: 995,222

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 25

HighFDA (Devices)··2016-08-24
Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Argon Modified Flat l Electrodes due to a potential sterile barrier breach.
Product
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
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ModerateFDA (Devices)··2016-08-24
Medtronic Recalls Laparoscopic Argon Sharp Needle Electrodes Due to Sterile Barrier Risk
Medtronic is recalling 210 units of Valleylab Laparoscopic Argon Sharp Needle Electrodes due to a potential sterile barrier breach.
Product
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
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0 states
HighFDA (Devices)··2016-08-24
Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers units distributed worldwide.
Product
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 sin
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0 states
HighFDA (Devices)··2016-08-24
Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk
Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.
Product
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
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0 states
HighFDA (Devices)··2016-08-24
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.
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 vi
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HighFDA (Devices)··2016-08-24
Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Cylindrical Tip Electrodes due to a potential sterile barrier breach. The recall covers units distributed worldwide.
Product
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 si
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0 states
HighFDA (Devices)··2016-08-24
Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Product
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
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0 states
HighFDA (Devices)··2016-08-24
Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk
Medtronic is recalling 19,200 Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Product
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
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0 states
HighFDA (Devices)··2016-08-24
Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk
Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Product
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
Category
Distribution
0 states
HighFDA (Devices)··2016-08-24
Medtronic Recalls Valleylab Laparoscopic Wire J-Hook Electrode Due to Sterility Risk
Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes due to a potential package compromise that could breach the sterile barrier.
Product
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
Category
Distribution
0 states
SevereFDA (Devices)··2016-08-24
Medtronic Valleylab Laparoscopic Electrode Recalled for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Flat L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 119,770 units distributed worldwide.
Product
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
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0 states
HighFDA (Devices)··2016-08-24
Medtronic Recalls Laparoscopic Electrodes Due to Sterile Barrier Compromise
Medtronic is recalling 1,440 Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Product
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 sucti
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0 states
ModerateFDA (Devices)··2016-08-24
Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Flexible Argon Blade Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Product
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 an
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0 states
ModerateFDA (Devices)··2016-08-24
Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk
Medtronic is recalling 332 Valleylab Laparoscopic Flat L-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Product
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
Category
Distribution
0 states
SevereFDA (Devices)··2016-08-24
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 50,055 units distributed worldwide.
Product
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 v
Category
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0 states
ModerateFDA (Devices)··2016-08-24
Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk
Medtronic is recalling Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Product
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 v
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0 states
HighFDA (Devices)··2016-08-24
Medtronic Valleylab Laparoscopic Electrodes Recalled for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall affects 6,381 units distributed worldwide.
Product
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 sing
Category
Distribution
0 states
ModerateFDA (Devices)··2016-08-24
Medtronic Valleylab Laparoscopic Electrodes Recalled for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach that could compromise the package integrity.
Product
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 sing
Category
Distribution
0 states
HighFDA (Devices)··2016-08-24
Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers lots 209358X through 60870083X distributed worldwide.
Product
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 s
Category
Distribution
0 states
ModerateFDA (Devices)··2016-08-24
Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Product
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
Category
Distribution
0 states
ModerateFDA (Devices)··2016-08-24
Medtronic Valleylab Laparoscopic Spatula Electrode Recall for Sterile Barrier Risk
Medtronic is recalling Valleylab Laparoscopic Straight Spatula Electrodes due to a potential sterile barrier breach. The recall affects 13,516 units distributed worldwide.
Product
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 si
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0 states
ModerateFDA (Devices)··2016-08-24
Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk
Medtronic is recalling Valleylab Laparoscopic AP Argon Blunt Needle Electrodes because the package may be compromised, potentially breaching the sterile barrier.
Product
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
Category
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0 states
HighFDA (Devices)··2016-08-24
Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk
Medtronic is recalling Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Product
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
Category
Distribution
0 states
ModerateFDA (Devices)··2016-08-24
Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise
Medtronic is recalling 6,720 Valleylab Laparoscopic Straight Spatula Electrodes because the package may be compromised, potentially breaching the sterile barrier.
Product
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 s
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0 states
HighFDA (Devices)··2016-08-24
Medtronic Recalls Laparoscopic Electrode Due to Sterile Barrier Compromise Risk
Medtronic is recalling 3,470 Valleylab Laparoscopic Flat L-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.
Product
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
Category
Distribution
0 states