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

Lot, batch or date codesLot 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 TRS100SB2: 201805095 201806055 201809265 201810314 201811224 201812114 201805144 201806115 201809285 201811054 201811234 201812124 201805145 201807134 201810014 201811064 201811264 201812144 201805194 201807245 201810094 201811074 201811274 201812174 201805214 201808155 201810154 201811084 201811284 201812184 201805255 201808164 201810164 201811124 201811304 201812204 201805284 201808165 201810184 201811134 201812034 201812214 201805295 201808205 201810194 201811144 201812044 201901024 201805315 201808214 201810224 201811154 201812054 201901034 201806015 201808225 201810234 201811164 201812064 201901044 201806045 201808234 201810244 201811204 201812074 201901074 201806054 201809255 201810254 201811214 201812104 -----

Quantity recalled69385

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-1304-2019
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 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 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.

Nationwide

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 TRS100SB2: 201805095 201806055 201809265 201810314 201811224 201812114 201805144 201806115 201809285 201811054 201811234 201812124 201805145 201807134 201810014 201811064 201811264 201812144 201805194 201807245 201810094 201811074 201811274 201812174 201805214 201808155 201810154 201811084 201811284 201812184 201805255 201808164 201810164 201811124 201811304 201812204 201805284 201808165 201810184 201811134 201812034 201812214 201805295 201808205 201810194 201811144 201812044 201901024 201805315 201808214 201810224 201811154 201812054 201901034 201806015 201808225 201810234 201811164 201812064 201901044 201806045 201808234 201810244 201811204 201812074 201901074 201806054 201809255 201810254 201811214 201812104 -----

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 82478

Reported	Class	Recall	Company	Reason	Where
15 May 2019	CLASS II	Anchor Tissue Retrieval System (3/BX) recalled by Conmed	Conmed	Sterility	Nationwide
15 May 2019	CLASS II	Anchor Tissue Retrieval System, VATS (3/BX) recalled by Conmed	Conmed	Sterility	Nationwide
15 May 2019	CLASS II	Anchor Tissue Retrieval System (3/BX) recalled by Conmed	Conmed	Sterility	Nationwide
15 May 2019	CLASS II	Anchor Tissue Retrieval System (5/BX) recalled by Conmed	Conmed	Sterility	Nationwide
15 May 2019	CLASS II	Anchor Tissue Retrieval System" (5/BX) recalled by Conmed	Conmed	Sterility	Nationwide

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All 92

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24 Jun 2026Device	CLASS II	AirSeal Access Port and Low Profile Obturator recalled by ConMed	ConMed	Packaging Defects	Nationwide

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14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
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