openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 22
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.
Code information
Part number: 470001-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 2 of 22
8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.
Code information
Part number: 470006-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 3 of 22
8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number: 470033-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 4 of 22
8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number:470093-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 5 of 22
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number: 470171-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 6 of 22
8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number: 470093-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 7 of 22
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number: 470172-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 8 of 22
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number: 470179-04 All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 9 of 22
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number: 470181-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 10 of 22
8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number:470183-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 11 of 22
8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number 470184-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 12 of 22
8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number 470205-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 13 of 22
8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number; 470207-04 All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 14 of 22
8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number;470215-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 15 of 22
8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number; 470246-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 17 of 22
8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number; 470249-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 18 of 22
8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number; 470309-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 19 of 22
8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number; 470318-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 20 of 22
8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number; 470327-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 21 of 22
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number; 470344-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
device · product 22 of 22
8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
These labels are deterministic app interpretations, not FDA categories.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Code information
Part number; 470347-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Distribution pattern
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
