CLASS II ONGOING Device recall · Reported 27 Mar 2019 · FDA Enforcement Report

Forceps Blue, disposable, sterile, 100 eaches per sales unit recalled

ConvaTec is recalling Forceps Blue, disposable, sterile, 100 eaches per sales unit, distributed nationwide in the US. The recall was initiated on 9 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code/REF Number: 417389; Lot Codes: 167069, 168288, 171981, 176327, 179936, 182217, 187735, 225174, 231247, 231248, 307362, 307578, 308189, 318432, 318433, 318434, 489868, 489951, 490747, 493969

Quantity recalled24,822,068 devices total

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-1035-2019
FDA event ID: 82039
Recalling firm: ConvaTec, Greensboro, NC
Classification: Class II
Status: Ongoing
Recall initiated: 9 Jan 2019
FDA classified: 21 Mar 2019
Reported: 27 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

9 Jan 2019	Recall initiated by company
21 Mar 2019	Classified by FDA	+71 days
27 Mar 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

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

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

Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forceps may be used in conditions where it is difficult to grasp small objects by hand and increased precise function is required. Applications in which sterile forceps are commonly used include wound care: e.g. gripping, debridement procedures, removal of sutures, arrangement of dressing procedure pack contents, dressing wounds, including cavity wounds and removal of wound tissue.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.

Nationwide Illinois Michigan Pennsylvania Wisconsin

Questions about this recall

Why was it recalled?

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

Which lots are affected?

Product Code/REF Number: 417389; Lot Codes: 167069, 168288, 171981, 176327, 179936, 182217, 187735, 225174, 231247, 231248, 307362, 307578, 308189, 318432, 318433, 318434, 489868, 489951, 490747, 493969

Where was it sold?

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

3 other products · FDA event 82039

This product is part of a recall event; the main page for the event is Nelaton Urinary Catheter, disposable, sterile recalled by ConvaTec.

Reported	Class	Recall	Company	Reason	Where
27 Mar 2019	CLASS II	Nelaton Urinary Catheter, disposable, sterile recalled by ConvaTec	ConvaTec	Sterility	Nationwide
27 Mar 2019	CLASS II	Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit recalled	ConvaTec	Sterility	Nationwide
27 Mar 2019	CLASS II	FilterFlow Suction Handle CH24, 20 eaches per sales unit recalled	ConvaTec	Sterility	Nationwide

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All 54

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Other Surgical Instruments recalls

All 3,816

Reported	Class	Recall	Company	Reason	Where
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23 Sep 2026Device	CLASS II	REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide