CLASS II Device recall · Reported 15 May 2019 · FDA Enforcement Report
Anchor Tissue Retrieval System" (5/BX) recalled by Conmed
Conmed is recalling Anchor Tissue Retrieval System" (5/BX), distributed nationwide in the US. The recall was initiated on 21 Mar 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1309-2019
- FDA event ID
- 82478
- Recalling firm
- Conmed, Utica, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Mar 2019
- FDA classified
- 9 May 2019
- Reported
- 15 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 21 Mar 2019 | Recall initiated by company | |
| 9 May 2019 | Classified by FDA | +49 days |
| 15 May 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
Where it was distributed
Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden.
Questions about this recall
Why was it recalled?
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
Which lots are affected?
Lot codes for product manufactured to and including the dates listed below, with the exclusions noted below for each catalog number: Beginning Manufacture Date: April 26, 2018 Beginning Lot Code: 20180426X Ending Manufacture Date: February 15, 2019 Ending Lot Code: 20190215X Excluded Anchor Tissue Retrieval System" Lot Codes - 1. All alpha/numeric lot codes (e.g. lots 68A8T or 19A8T) 2. All numeric lot codes ending with the number 9 (e.g. Lot code 201902159) 3. All excluded numeric lot codes listed in the tables below for each specific catalog number: Excluded Lot Codes for Cat. Number TRS-ROBO-12: 201901084, 201901104, 201901144, 201901094, 201901114
Where was it sold?
Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 82478This product is part of a recall event; the main page for the event is Anchor Tissue Retrieval System, (5/BX) recalled by Conmed.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Anchor Tissue Retrieval System, (5/BX) recalled by Conmed | Conmed | Sterility | Nationwide | |
| CLASS II | Anchor Tissue Retrieval System (3/BX) recalled by Conmed | Conmed | Sterility | Nationwide | |
| CLASS II | Anchor Tissue Retrieval System, VATS (3/BX) recalled by Conmed | Conmed | Sterility | Nationwide | |
| CLASS II | Anchor Tissue Retrieval System (3/BX) recalled by Conmed | Conmed | Sterility | Nationwide | |
| CLASS II | Anchor Tissue Retrieval System (5/BX) recalled by Conmed | Conmed | Sterility | Nationwide |
More recalls from Conmed
All 92| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |
| Device | CLASS II | AirSeal Access Port and Palm Grip Obturator recalled by ConMed | ConMed | Packaging Defects | Nationwide |
| Device | CLASS II | AirSeal Access Port and Obturator with Blunt Tip Length recalled | ConMed | Packaging Defects | Nationwide |
| Device | CLASS II | AirSeal Access Port and Low Profile Obturator recalled by ConMed | ConMed | Packaging Defects | Nationwide |
| Device | CLASS II | AirSeal Access Port and Low Profile Obturator recalled by ConMed | ConMed | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |