510(k) Report

510(k) · Decided

Recalled · Class II · 2015

Intutive Surgical DA Vinci Single Site Instruments and Accessories

K112208510(k) TraditionalDecided Dec 8, 2011129-day reviewClass II21 CFR 876.1500Recalls 12

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Intuitive Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument

Cleared on Dec 8, 2011 as substantially equivalent to K081137 (Intuitive Surgical, Inc., 2009) and 4 other predicates after a 129-day review. Its family tree reaches back 11 generations to 1994. 43 later devices descend from it. It has been recalled 12 times.

Decided
Dec 8, 2011
Review
129 days
Class
Class II
Product code
NAY
Recalls
12
Predicates
5

Its longest line of descent runs back 11 generations to K930667 (1994). 72 ancestors in all, the oldest K811390 (1981). 43 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 2 other ancestors2008: 2 other ancestors2007: 2 other ancestors2005: 2 other ancestors2003: 1 other ancestor2001: 8 other ancestors1998: 3 other ancestors1995: 6 other ancestors1994: 6 other ancestors2002: 3 other ancestors1996: 1 other ancestor1993: 3 other ancestors1992: 3 other ancestors1991: 3 other ancestors1988: 2 other ancestors2006: 1 other ancestor2004: 3 other ancestors1997: 6 other ancestors1999: 2 other ancestors1981: 1 other ancestor2013: 2 descendants cleared2014: 4 descendants cleared2012: 1 descendant cleared2017: 2 descendants cleared2016: 1 descendant cleared2018: 3 descendants cleared2015: 1 descendant cleared2019: 2 descendants cleared2024: 6 descendants cleared2020: 3 descendants cleared2025: 8 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2021: 3 descendants cleared2022: 1 descendant clearedK930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalled×5: 5 generations cleared close together, K040237 (2004), K043153 (2004), K050005 (2005), K050404 (2005), K050802 (2005) K063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 8 other ancestors3 generations back: 15 other ancestors4 generations back: 14 other ancestors5 generations back: 9 other ancestors6 generations back: 6 other ancestors7 generations back: 5 other ancestors 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 6 descendants6 generations forward: 5 descendants7 generations forward: 4 descendants8 generations forward: 3 descendants9 generations forward: 3 descendants10 generations forward: 5 descendants K081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK050802 · Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050404 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050005 · Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180 · Intuitive Surgical, Inc. · 2005 · recalledK043153 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 · Intuitive Surgical, Inc. · 2004K040237 · Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2004K021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalledK990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalled−10−50+5+10
  1. Root · 11 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 7 generations between
  3. 3 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  4. 2 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  5. 1 generation backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  6. This deviceK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011
  7. Descendant · cites it directly · 42 of its ownK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled
  8. Descendant · cites it directly · 39 of its ownK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled
  9. Descendant · cites it directly · 22 of its ownK131962 DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014
  10. Descendant · 2 generations on · 21 of its ownK173906 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · Recalled
  11. Descendant · 3 generations on · 20 of its ownK182371 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2019 · Recalled
Show all 11 generations
  1. Root · 11 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 10 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 9 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 8 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 7 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. 6 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. 5 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. 4 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. 3 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  10. 2 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  11. 1 generation backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  12. This deviceK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2012: 12013: 22014: 42015: 12016: 12017: 22018: 32019: 22020: 32021: 32022: 12023: 32024: 62025: 82026: 3
2012high 8 (2025) · low 1 (2012)2026

Most influential descendants

Showing 5 of 43 · See all
  • K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc. · 2012 · cites it directly42descendants
  • K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · cites it directly39descendants
  • K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014 · cites it directly22descendants
  • K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · 2 generations on21descendants
  • K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2019 · 3 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−10K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−9K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−8K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−7K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
−6K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
−5K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
−4K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
−3K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—
−2K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20064
−1K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200925
0 (this device)K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.2011—
+1K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc.20123
+1K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.20136
+1K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2014—
+2K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.20189
+3K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.20194

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198820
199130
199230
199330
199460
199560
199610
199760
199830
199920
200180
200230
200310
200430
200520
200610
200720
200820
200920
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201320
201440
201510
201610
201720
201830
201920
202030
202130
202210
202330
202460
202580
202630
FIG. 1 — Lineage of K112208, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NAY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NAY device

  1. #1 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200925
*K082619Sils Port, Models SILSPT5, SILSPT12
Summary page 1
…Surgical 1S3000 do Vinci Si Surgical System with~Instruments and Accessories (KOB81137) " Covidien SILSTM Port, (cleared under K0826 19) * Transenterix Spider Surgical Instruments (K09 1697) " Transenterix Spider Flex Monopol…
Covidien Lp, Formerly Registered AS United States2008—
*K091697Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
Summary page 1
…and Accessories (KOB81137) " Covidien SILSTM Port, (cleared under K0826 19) * Transenterix Spider Surgical Instruments (K09 1697) " Transenterix Spider Flex Monopolar Hook (K102646) " Transenterix Spider Single Port Su…
Transenterix, Inc.20092
*K102646Spider Flex Monopolar Hook
Summary page 1
…M Port, (cleared under K0826 19) * Transenterix Spider Surgical Instruments (K09 1697) " Transenterix Spider Flex Monopolar Hook (K102646) " Transenterix Spider Single Port Surgical Device, Support Arm Accessory (K090902) De…
Transenterix, Inc.2010—
*K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003
Summary page 1
…" Transenterix Spider Flex Monopolar Hook (K102646) " Transenterix Spider Single Port Surgical Device, Support Arm Accessory (K090902) Device Description: The do Vinci Single-Site Instruments and Accessories are a new set of devices developed by Intuitive Surgi…
Transenterix, Inc.20091

Also cleared against K081137: 28 other devices →

What descends from it? (43)

See all 43

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc.201242
K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.201339
K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.201422
K130726DA Vinci Single-Site Permanent Cautery HookIntuitive Surgical, Inc.20132

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 8, 2015Class IIZ-2756-2015Device DesignIn certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Aug 8, 2015Class IIZ-2757-2015Device DesignIn certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Aug 8, 2015Class IIZ-2752-2015Device DesignIn certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Aug 8, 2015Class IIZ-2753-2015Device DesignIn certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Aug 8, 2015Class IIZ-2750-2015Device DesignIn certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Aug 8, 2015Class IIZ-2758-2015Device DesignIn certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Mar 13, 2014Class IIZ-1333-2014Device DesignIntuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct…
Mar 13, 2014Class IIZ-1332-2014Device DesignIntuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct…
Mar 13, 2014Class IIZ-1335-2014Device DesignIntuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct…
Mar 13, 2014Class IIZ-1334-2014Device DesignIntuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct…
Oct 2, 2013Class IIZ-0110-2014Labeling Change ControlA limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional…
Oct 2, 2013Class IIZ-0111-2014Labeling Change ControlA limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional…

The 5 latest of 12 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
  • 13 of the 72 ancestors have a recall of any class.
  • Of its descendants, K120215 (Intuitive Surgical, Inc., 2012) has gone furthest, with 42 descendants of its own.
  • 28 other devices also cite its predicate K081137.

How does its category compare?

All NAY devices

NAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · NAY

16in 2025

2008: 42009: 32010: 12011: 72012: 42013: 42014: 92015: 32016: 82017: 162018: 152019: 82020: 92021: 112022: 62023: 52024: 102025: 162026 (partial year): 7
2007high 16 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NAY

117in 2025

2008: 189 days median2009: 253 days median2011: 191 days median2012: 106 days median2013: 144 days median2014: 143 days median2015: 99 days median2016: 197 days median2017: 107 days median2018: 152 days median2019: 73 days median2020: 212 days median2021: 61 days median2022: 57 days median2023: 141 days median2024: 126 days median2025: 117 days median2026 (partial year): 89 days median
2007high 253 (2009) · low 57 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NAY

1in 2025

2007: 112008: 32009: 12011: 22012: 12013: 62014: 252015: 32016: 12017: 12018: 22019: 52021: 32022: 32023: 2, 1 Class I2024: 402025: 12026 (partial year): 4, 1 Class I
2007high 40 (2024) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NAY

48,456in 2025

2007: 1332008: 2242009: 3802010: 6232011: 5012012: 1,5522013: 6,2172014: 6,1352015: 1,7222016: 1,0772017: 1,0492018: 1,0742019: 1,1542020: 1,5582021: 1,9972022: 5,7272023: 10,8982024: 12,8722025: 48,456
2007high 48,456 (2025) · low 133 (2007)2025

MAUDE reports naming product code NAY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—11133
200841893224
200932531380
20101—0623
201171912501
2012410611,552
2013414466,217
20149143256,135
201539931,722
2016819711,077
20171610711,049
20181515221,074
201987351,154
2020921201,558
2021116131,997
202265735,727
202351412 (1)10,898
2024101264012,872
202516117148,456
20267894 (1)—

What is it indicated for?

The Intuitive Surgical do Vinci Single-Site Instruments and Accessories used with the do Vinci Si Surgical System (153000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip- ligation and electrocoutery during single incision laparoscopic cholecysteclomy with the do Vinci Single Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5mm curved cannulae, 5mm and 1Omm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.

Indications for use as stated in the FDA summary.

Also cleared against K081137

28 other devices cite the same predicate.

  • K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix · 2025
  • K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix · 2025
  • K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix · 2025
  • K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix · 2025
  • K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix · 2024
  • K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc. · 2022

More from Intuitive Surgical, Inc.

181 FDA decisions under this applicant name. See the company

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc. · 2026
  • K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K261249Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2026

Recent decisions in NAY

The NAY category page

  • K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K260695da Vinci Firefly Imaging SystemIntuitive Surgical · 2026
  • K254192Senhance Ultrasonic SystemAsensus Surgical · 2026
  • K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc. · 2026

https://510kreport.com/device/K112208 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112208: Intutive Surgical DA Vinci Single Site Instruments and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112208

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026