Device recall: PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia…
Class II FDA enforcement event 69838. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
The recalling firm started this device recall on 17 Nov 2014. The FDA record names a person as the firm, and this site does not show the name. The firm address in the FDA record is in San Jose, CA. FDA put the recall in Class II. FDA event 69838 has 207 product records. The first FDA enforcement report date is 24 Dec 2014. The record gives the status Terminated, with the termination date 17 Jul 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam,…
Recalling firm
The name is withheld, San Jose, CA.
The FDA record gives the name of a person as the recalling firm. This site does not show the names of persons.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
207 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0592-2015 | PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: 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,… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0593-2015 | PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0594-2015 | PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0595-2015 | PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0596-2015 | PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0597-2015 | PKG, OP-BIOPSY FORCEPS, SPOON JAW, P/N 0250080007 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0598-2015 | PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0599-2015 | PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0600-2015 | PKG, MYOMA DRILL 5MM LENGTH 320MM, P/N 0250080133 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0601-2015 | PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0602-2015 | PKG, PORTIO ACORN SMALL ONLY, P/N 0250080139; 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0603-2015 | PKG, TROCAR 5.5MM PYRAMIDAL TIP, P/N 0250080154; 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0604-2015 | PKG, OBTURATOR, 5.5MM FOR HASSON CANNULA, P/N 0250080157; 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0605-2015 | PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0606-2015 | PKG, MARYLAND FORCEPS, CURVED, P/N 0250080009. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0607-2015 | PKG, HASSON CANNULA, 5.5MM, AUTOMATIC VALVE, STOP COCK, P/N 0250080176. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0608-2015 | PKG, MIXTER FORCEPS, P/N 0250080010. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0609-2015 | PKG, HOOK SCISSORS, P/N 0250080020. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0610-2015 | PKG, HASSON CANNULA, 11MM AUTOMATIC VALVE, STOP COCK, P/N 0250080179. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0611-2015 | PKG, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0612-2015 | PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080024. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0613-2015 | PKG, METZENBAUM SCISSORS, CURVED, LONG, P/N 0250080025. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0614-2015 | PKG, BABY METZENBAUM SCISSORS, CURVED, P/N 0250080028. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0615-2015 | PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080029. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0616-2015 | PKG, 12.5/11MM - 5.5 REDUCER, P/N 0250080204. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0617-2015 | PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0618-2015 | PKG, LUERLOCK, MALE, 6MM TUBING, P/N 0250080207. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0619-2015 | PKG, LUERLOCK, FEMALE, 6MM TUBING, P/N 0250080208. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0620-2015 | PKG, MARYLAND FORCEPS, CURVED, LEFT, P/N 0250080042. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0621-2015 | PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080230. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0622-2015 | PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0623-2015 | PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0624-2015 | PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0625-2015 | PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0626-2015 | PKG, RING HANDLE, P/N 0250080236. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0627-2015 | PKG, SPRING HANDLE, P/N 0250080237. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0628-2015 | PKG, ALLIS FORCEPS, P/N 0250080240. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0629-2015 | PKG, BABCOCK FORCEPS, P/N 0250080241. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0630-2015 | PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080047 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0631-2015 | PKG, PENNINGTON FORCEPS, P/N 0250080242. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0632-2015 | PKG, CLAW FORCEPS, P/N 0250080244. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0633-2015 | PKG, CLAW FORCEPS, DOUBLE ACTION, P/N 0250080245. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0634-2015 | PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0635-2015 | PKG, OPERATING SCISSORS, SERRATED, P/N 0250080247. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0636-2015 | PKG, MARYLAND FORCEPS, CURVED, P/N 0250080248. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0637-2015 | PKG, MIXTER FORCEPS, P/N 0250080249. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0638-2015 | PKG, BABCOCK FORCEPS, PADDLE, P/N 0250080250. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0639-2015 | PKG, PKG, HOOK SCISSORS, P/N 0250080260. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0640-2015 | PKG, NEEDLE NOSE FORCEPS, P/N 0250080048. 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.… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0641-2015 | PKG, PKG, PERITONEAL SCISSORS, P/N 0250080262. 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… | 180,573 units total | Class II | Terminated | 24 Dec 2014 |
| Z-0642-2015 | PKG, METZENBAUM SCISSORS, STRAIGHT, LONG, P/N 0250080263. 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… | 180,573 units | Class II | Terminated | 24 Dec 2014 |
| Z-0643-2015 | PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080264. 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… | 180,573 units | Class II | Terminated | 24 Dec 2014 |
| Z-0644-2015 | PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. 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… | 180,573 units | Class II | Terminated | 24 Dec 2014 |
| Z-0645-2015 | PKG, MINI METZENBAUM SCISSORS, CURVED LONG, P/N 0250080266. 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… | 180,573 units | Class II | Terminated | 24 Dec 2014 |
| Z-0646-2015 | PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. 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… | 180,573 units | Class II | Terminated | 24 Dec 2014 |
| Z-0647-2015 | PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080071. 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… | 180,573 units | Class II | Terminated | 24 Dec 2014 |
| Z-0648-2015 | PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269. 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… | 180,573 units | Class II | Terminated | 24 Dec 2014 |
| Z-0649-2015 | PKG, MICRO SCISSORS, CURVED, P/N 0250080270. 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.… | 180,573 units | Class II | Terminated | 24 Dec 2014 |
| Z-0650-2015 | 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… | 180,573 units | Class II | Terminated | 24 Dec 2014 |
| Z-0651-2015 | 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… | 180,573 units | Class II | Terminated | 24 Dec 2014 |
The table shows 60 of 207 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 207
Official channels
- FDA enforcement report Z-0592-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 69838. https://recallregister.com/fda/ii/69838/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam,…
- What quantity of product is in FDA event 69838?
- The event has 207 product records. The first record gives this quantity:
180,573 units total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.