Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise
Medtronic is recalling 1,293,169 Clearify Visualization Systems because a breach of the sterile barrier compromises product sterility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a medical device with a compromised sterile barrier (a significant safety risk) is categorized as Severe.
Plain-English summary
Medtronic is recalling 1,293,169 units of the Covidien Clearify Visualization System (Item Code: 21-345). This medical device is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope and clean the scope lens.
The recall is being conducted because the product sterility is compromised due to a breach of the sterile barrier. The affected lots include those beginning with P4J, P4K, P4L, P4M, P5A through P5M, P6A through P6D, and specific lots P6E0016GX, P6E0049GX, P6E0050GX, P6E0051GX, P6E0052GX, P6E0163GX, P6E0164GX, and P6E0212GX.
The product was distributed worldwide, including nationwide in the United States and in numerous foreign countries such as Austria, Belgium, Brazil, France, Germany, Japan, and the United Kingdom. Healthcare facilities and users should stop using the affected devices and contact Medtronic for further instructions.
The recalled product
- Product
- Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
- Manufacturer
- Medtronic
- Affected units
- 1,293,169
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)
- Lots beginning with: P4J
- P4K
- P4L
- P4M
- P5A
- P5B
- P5C
- P5D
- P5E
- P5F
- P5G
- P5H
- P5J
- P5K
- P5L
- P5M
- P6A
- P6B
- P6C
- P6D and lots P6E0016GX
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 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
- HighMedtronic Recalls MAXON Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighMedtronic Recalls Laparoscopic Electrodes Due to Sterile Barrier Compromise
FDA (Devices) · 2016-08-24
- ModerateMedtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise
FDA (Devices) · 2016-08-24
- ModerateMedtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk
FDA (Devices) · 2016-08-24
- HighMedtronic Recalls Laparoscopic Electrode Due to Sterile Barrier Compromise Risk
FDA (Devices) · 2016-08-24
- SevereRecall of Sterile Eye Pads Due to Compromised Sterility Barrier
FDA (Devices) · 2017-04-12
- HighMedtronic Recalls Patient Tracker Devices Due to Sterility Control Issues
FDA (Devices) · 2014-11-26