Device recall: 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Class II FDA enforcement event 95938. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
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
Intuitive Surgical, Inc. started this device recall on 19 Dec 2024. The firm address in the FDA record is in Sunnyvale, CA. FDA put the recall in Class II. FDA event 95938 has 37 product records. The first FDA enforcement report date is 22 Jan 2025. The record gives the status Ongoing.
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.
U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky,…
Recalling firm
Intuitive Surgical, Inc., Sunnyvale, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
37 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0847-2025 | 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 | 355,547 | Class II | Ongoing | 22 Jan 2025 |
| Z-0848-2025 | 8MM, POTTS SCISSORS, IS4000 REF 470001 | 3,625 | Class II | Ongoing | 22 Jan 2025 |
| Z-0849-2025 | 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 | 10,603 | Class II | Ongoing | 22 Jan 2025 |
| Z-0850-2025 | 8MM, ROUND TIP SCISSORS, IS4000 REF 470007 | 4,259 | Class II | Ongoing | 22 Jan 2025 |
| Z-0851-2025 | 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 REF 470033 | 1,111 | Class II | Ongoing | 22 Jan 2025 |
| Z-0852-2025 | 8MM,DEBAKEY FORCEPS,IS4000 REF 470036 | 1,739 | Class II | Ongoing | 22 Jan 2025 |
| Z-0853-2025 | 8MM,CADIERE FORCEPS,IS4000 REF 470049 | 8,578 | Class II | Ongoing | 22 Jan 2025 |
| Z-0854-2025 | 8MM,PROGRASP FORCEPS,IS4000 REF 470093 | 2,852 | Class II | Ongoing | 22 Jan 2025 |
| Z-0855-2025 | 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 470171 | 178 | Class II | Ongoing | 22 Jan 2025 |
| Z-0856-2025 | 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 470172 | 7,132 | Class II | Ongoing | 22 Jan 2025 |
| Z-0857-2025 | 8MM,RESANO FORCEPS,IS4000 REF 470181 | 373 | Class II | Ongoing | 22 Jan 2025 |
| Z-0858-2025 | 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194 | 38,438 | Class II | Ongoing | 22 Jan 2025 |
| Z-0859-2025 | 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205 | 12,340 | Class II | Ongoing | 22 Jan 2025 |
| Z-0860-2025 | 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207 | 11,162 | Class II | Ongoing | 22 Jan 2025 |
| Z-0861-2025 | 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230 | 29,559 | Class II | Ongoing | 22 Jan 2025 |
| Z-0862-2025 | 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246 | 738 | Class II | Ongoing | 22 Jan 2025 |
| Z-0863-2025 | 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249 | 783 | Class II | Ongoing | 22 Jan 2025 |
| Z-0864-2025 | 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296 | 784 | Class II | Ongoing | 22 Jan 2025 |
| Z-0865-2025 | 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309 | 12 | Class II | Ongoing | 22 Jan 2025 |
| Z-0866-2025 | 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318 | 9,303 | Class II | Ongoing | 22 Jan 2025 |
| Z-0867-2025 | 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327 | 30,316 | Class II | Ongoing | 22 Jan 2025 |
| Z-0868-2025 | 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344 | 141 | Class II | Ongoing | 22 Jan 2025 |
| Z-0869-2025 | 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347 | 72,646 | Class II | Ongoing | 22 Jan 2025 |
| Z-0870-2025 | 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401 | 5,576 | Class II | Ongoing | 22 Jan 2025 |
| Z-0871-2025 | 8MM,FORCE BIPOLAR,IS4000 REF 470405 | 4 | Class II | Ongoing | 22 Jan 2025 |
| Z-0872-2025 | 8MM,LONG TIP FORCEPS,IS4000 REF 471048 | 1,562 | Class II | Ongoing | 22 Jan 2025 |
| Z-0873-2025 | 8MM,CADIERE FORCEPS,IS4000 REF 471049 | 56,580 | Class II | Ongoing | 22 Jan 2025 |
| Z-0874-2025 | 8MM,PROGRASP FORCEPS,IS4000 REF 471093 | 99,249 | Class II | Ongoing | 22 Jan 2025 |
| Z-0875-2025 | 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 | 1,036 | Class II | Ongoing | 22 Jan 2025 |
| Z-0876-2025 | 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 | 68,458 | Class II | Ongoing | 22 Jan 2025 |
| Z-0877-2025 | 8MM,COBRA GRASPER,IS4000 REF 471190 | 2,472 | Class II | Ongoing | 22 Jan 2025 |
| Z-0878-2025 | 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 | 147,006 | Class II | Ongoing | 22 Jan 2025 |
| Z-0879-2025 | 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 | 29,723 | Class II | Ongoing | 22 Jan 2025 |
| Z-0880-2025 | 8MM,MEGA SUTURECUT ND,IS4000 REF 471309 | 88,840 | Class II | Ongoing | 22 Jan 2025 |
| Z-0881-2025 | 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 | 3,869 | Class II | Ongoing | 22 Jan 2025 |
| Z-0882-2025 | 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 | 14,507 | Class II | Ongoing | 22 Jan 2025 |
| Z-0883-2025 | 8MM,FORCE BIPOLAR,IS4000 REF 471405 | 46,759 | Class II | Ongoing | 22 Jan 2025 |
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 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 37Median of the firm: 1
- Events of the firm on the register
- 105
Other events of the firm
Official channels
- FDA enforcement report Z-0847-2025The 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 95938. https://recallregister.com/fda/ii/95938/. 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:
U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky,…
- What quantity of product is in FDA event 95938?
- The event has 37 product records. The first record gives this quantity:
355,547
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.