CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report
Pkg, Bullet Forceps, Tapered, Serrated, Spoon recalled
Stryker Endoscopy is recalling Pkg, Bullet Forceps, Tapered, 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
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-0651-2015
- 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, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080281. 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.
Questions about this recall
Is Pkg, Bullet Forceps, Tapered, Serrated, Spoon recalled?
Yes. Stryker Endoscopy recalled Pkg, Bullet Forceps, Tapered, Serrated, Spoon on 17 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0651-2015.
Why was it recalled?
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
Which lots are affected?
140858 641146 746194 843737 844140 844170 845049 845504 945743 1040578 1040594 1041477 1042231 1042477 1042658 1042662 1043229 1142623 1144483 1145285 1146682 1244079 1244533 1245453 1246129 1341529 1342146 1342761 1343009
Where was it sold?
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.
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.
More recalls from Stryker Endoscopy
All 238| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
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| Device | CLASS II | Pkg, Pennington Forceps recalled by Stryker Endoscopy | Stryker Endoscopy | Sterility | Nationwide |
| Device | CLASS II | Pkg Peek Handle recalled by Stryker Endoscopy | Stryker Endoscopy | Sterility | Nationwide |
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| 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 |