CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report

Pkg, Dolphin Forceps, Serrated Spoon recalled by Stryker Endoscopy

Stryker Endoscopy is recalling Pkg, Dolphin Forceps, Serrated Spoon, distributed nationwide in the US. The recall was initiated on 17 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes44411 140587 641149 644759 743486 744853 840512 840696 846768 847022 940075 940789 941063 942138 943425 943746 944668 944833 945446 1040593 1040936 1041993 1042655 1042656 1042657 1142000 1142622 1142919 1143080 1143700 1143975 1144397 1144619 1144992 1146362 1240537 1241178 1241457 1243803 1244170 1244532 1245025 1245026 1341526 1341994 1342762 1344294 1344877 1440444 1442629 1443580 645726

Quantity recalled180,573 units

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-0650-2015
FDA event ID: 69838
Recalling firm: Stryker Endoscopy, San Jose, CA
Classification: Class II
Status: Terminated
Recall initiated: 17 Nov 2014
FDA classified: 17 Dec 2014
Reported: 24 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

17 Nov 2014	Recall initiated by company
17 Dec 2014	Classified by FDA	+30 days
24 Dec 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods

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

PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

Nationwide Puerto Rico

Questions about this recall

Is Pkg, Dolphin Forceps, Serrated Spoon recalled?

Yes. Stryker Endoscopy recalled Pkg, Dolphin Forceps, Serrated Spoon on 17 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0650-2015.

Why was it recalled?

Which lots are affected?

44411 140587 641149 644759 743486 744853 840512 840696 846768 847022 940075 940789 941063 942138 943425 943746 944668 944833 945446 1040593 1040936 1041993 1042655 1042656 1042657 1142000 1142622 1142919 1143080 1143700 1143975 1144397 1144619 1144992 1146362 1240537 1241178 1241457 1243803 1244170 1244532 1245025 1245026 1341526 1341994 1342762 1344294 1344877 1440444 1442629 1443580 645726

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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