INSTRUMENT ARM DRAPE, IS4000, 20 PACK
Medical device recall Z-1949-2015. Published in FDA’s Enforcement Report on Jul 8, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 8, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 310 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is 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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. A pinched drape may cause a message on the Vision Cart touchscreen - Missing reload error.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
310, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Manufacturing lot numbers: 470015-05, 470015-06. System numbers: SK0194 SK0312 SK0182 SK0195 SK0313 SK0241 SK0321 SK0131 SK0117 SK0149 SK0068 SK0197 SK0329 SK0185 SK0183 SK0253 SK0142 SK0141 SK0078 SK0128 SK0224 SK0192 SK0381 SK0085 SK0086…
Every code shown here, 1,997 characters
Manufacturing lot numbers: 470015-05, 470015-06. System numbers: SK0194 SK0312 SK0182 SK0195 SK0313 SK0241 SK0321 SK0131 SK0117 SK0149 SK0068 SK0197 SK0329 SK0185 SK0183 SK0253 SK0142 SK0141 SK0078 SK0128 SK0224 SK0192 SK0381 SK0085 SK0086 SK0247 SK0109 SK0088 SK0199 SK0200 SK0201 SK0215 SK0223 SK0336 SK0164 SK0256 SK0202 SK0214 SK0089 SK0165 SK0374 SK0374 SK0124 SK0260 SK0323 SK0252 SK0319 SK0327 SK0373 SK0335 SK0129 SK0184 SK0229 SK0110 SK0111 SK0350 SK0351 SK0136 SK0132 SK0190 SK0290 SK0158 SK0207 SK0341 SK0246 SK0226 SK0187 SK0232 SK0303 SK0328 SK0330 SK0315 SK0334 SK0204 SK0248 SK0344 SK0322 SK0219 SK0353 SK0222 SK0154 SK0318 SK0217 SK0196 SK0221 SK0172 SK0218 SK0220 SK0379 SK0213 SK0108 SK0177 SK0179 SK0101 SK0170 SK0233 SK0309 SK0234 SK0235 SK0105 SK0104 SD0002 SK0240 SK0360 SK0203 SK0091 SK0106 SK0206 SK0326 SK0294 SK0291 SK0237 SK0293 SK0238 SK0292 SK0272 SK0273 SK0356 SK0148 SK0095 SK0347 SK0135 SD0001 SK0259 SK0167 SK0371 SK0152 SK0087 SK0159 SK0225 SK0069 SK0099 SK0257 SK0178 SK0061 SK0343 SK0064 SK0163 SK0065 SK0180 SK0346 SK0285 SK0348 SK0280 SK0383 SK0239 SK0209 SK0258 SK0352 SK0331 SK0308 SK0271 SK0264 SK0358 SK0216 SK0039 SK0263 SK0162 SK0270 SK0059 SK0120 SK0143 SK0144 SK0279 SK0338 SK0265 SK0267 SK0051 SK0266 SK0316 SK0339 SK0145 SK0139 SK0074 SK0255 SK0314 SK0147 SK0186 SK0082 SK0295 SK0174 SK0055 SK0119 SK0058 SK0134 SK0242 SK0333 SK0250 SK0342 SK0302 SK0084 SK0092 SK0166 SK0090 SK0269 SK0114 SK0113 SK0375 SK0268 SK0296 SK0299 SK0168 SK0324 SK0300 SK0245 SK0083 SK0231 SK0287 SK0098 SK0298 SK0198 SK0275 SK0067 SK0066 SK0096 SK0254 SK0103 SK0230 SK0208 SK0070 SK0093 SK0332 SK0205 SK0044 SK0301 SK0094 SK0278 SK0286 SK0075 SK0317 SK0137 SK0349 SK0284 SK0122 SK0138 SK0146 SK0249 SK0320 SK0057 SK0228 SK0210 SK0079 SK0176 SK0155 SK0150 SK0156 SK0097 SK0307 SK0157 SK0288 SK0304 SK0244 SK0054 SK0123 SK0188 SK0189 SK0072 SK0175 SK0193 SK0062 SK0100 SK0382 SK0376 SK0173 SK0297 SK0261 SK0181 SK0063 SK0130 SK0359 SK0274 SK0112 SK0140 SK0262 SK0036 SK0236…
FDA’s list runs to 2,235 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Norway, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 16, 2015.
- FDA classified it on Jul 1, 2015.
- FDA’s Enforcement Report published it on Jul 8, 2015.
- FDA terminated it on Oct 5, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Intuitive Surgical, Inc., of Sunnyvale, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,235 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.