RetCam 3, RetCam Portable and RetCam Shuttle
Medical device recall Z-1154-2014. Published in FDA’s Enforcement Report on Mar 19, 2014.
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 Mar 19, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 28 states named
- 166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables. 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?
Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
no lot numbers: RetCam 3 (RC3, Part number 21-100500; Serial numbers: RC3125 RC6003 RC6004 RC6005 RC6006 RC6007 RC6008 RC6009 RC6010 RC6011 RC6012 RC6013 RC6014 RC6015 RC6016 RC6017 RC6018 RC6019 RC6020 RC6021 RC6022 RC6023 RC6024 RC6025…
Every code shown here, 1,995 characters
no lot numbers: RetCam 3 (RC3, Part number 21-100500; Serial numbers: RC3125 RC6003 RC6004 RC6005 RC6006 RC6007 RC6008 RC6009 RC6010 RC6011 RC6012 RC6013 RC6014 RC6015 RC6016 RC6017 RC6018 RC6019 RC6020 RC6021 RC6022 RC6023 RC6024 RC6025 RC6026 RC6027 RC6028 RC6029 RC6030 RC6031 RC6033 RC6034 RC6035 RC6036 RC6037 RC6038 RC6039 RC6040 RC6041 RC6042 RC6043 RC6044 RC6045 RC6046 RC6047 RC6048 RC6049 RC6050 RC6051 RC6052 RC6053 RC6054 RC6055 RC6056 RC6057 RC6058 RC6059 RC6060 RC6061 RC6062 RC6063 RC6064 RC6065 RC6066 RC6067 RC6068 RC6069 RC6070 RC6071 RC6072 RC6073 RC6074 RC6075 RC6076 RC6077 RC6078 RC6079 RC6080 RC6081 RC6082 RC6083 RC6084 RC6085 RC6086 RC6087 RC6088 RC6089 RC6090 RC6091 RC6092 RC6093 RC6094 RC6095 RC6096 RC6097 RC6098 RC6099 RC6100 RC6101 RC6102 RC6103 RC6104 RC6105 RC6106 RC6107 RC6108 RC6109 RC6110 RC6111 RC6112 RC6113 RC6300 RC6301 RC6302 RC6303 RC6304 RC6305 RC6306 RC6307 RC6308 RC6309 RC6310 RC6311 RC6312 RC6313 RC6314 RC6315 RC6316 RC6317 RC6318 RC6319 RC6320 RC6321 RC6322 RC6323 RC6324 RC6325 RC6326 RC6327 RC6328 RC6329 RC6330 RC6331 RC6332 RC6333 RC6334 RC6335 RC6336 RC6337 RC6338 RC6339 RC6340 RC6341 RC6342 RC6343 RC6344 RC6345 RC6346 RC6347 RC6348 RC6349 RC6350 RC6351 RC6352 RC6353 RC6354 RC6355 RC6356 RC6357 RC6358 RC6359 RC6360 RC6361 RC6362 RC6363 RC6364 RC6365 RC6366 RC6367 RC6368 RC6369 RC6370 RC6371 RC6372 RC6373 RC6374 RC6375 RC6376 RC6377 RC6378 RC6379 RC6380 RC6381 RC6382 RC6383 RC6384 RC6385 RC6386 RC6387 RC6388 RC6389 RC6390 RC6391 RC6392 RC6393 RC6394 RC6395 RC6396 RC6397 RC6398 RC6399 RC6400 RC6401 RC6402 RC6403 RC6404 RC6405 RC6406 RC6407 RC6408 RC6410 RC6411 RC6412 RC6413 RC6414 RC6415 RC6416 RC6417 RC6418 RC6419 RC6420 RC6421 RC6422 RC6423 RC6424 RC6425 RC6426 RC6427 RC6428 RC6429 RC6430 RC6431 RC6432 RC6433 RC6434 RC6435 RC6436 RC6437 RC6438 RC6439 RC6440 RC6441 RC6442 RC6443 RC6444 RC6445 RC6446 RC6447 RC6448 RC6449 RC6450 RC6451 RC6452 RC6453 RC6454 RC6455 RC6456 RC6457 RC6458 RC6459 RC6460 RC6461 RC6462 RC6463 RC6464…
FDA’s list runs to 3,530 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-USA (nationwide) including DC and the states of NM, LA, CA, MI, PR, GA, MD, MT, AL, MA, NY, IL, OH, TX, VA, MI, FL, MO, KY, TN, CT, NJ, PA, UT, SD, OK, MS, and NC and the countries of Algeria, Australia, Austria, Bangladesh, Belarus, The Netherlands, Brazil, Bulgaria, Chile, China, Columbia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France,India, Indonesia, Iran, United Kingdom, Israel, Italy, Kuwait, Lebanon, Malaysia, Mexico, Sweden, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Taiwan, Thailand, Turkey, UAE, Argentina, Uzbekistan, Oman, Canada, Germany, and Switzerland.
The states and territories these words name
28 states and territories.
Every one of them
- Alabama
- California
- Connecticut
- District of Columbia
- Florida
- Georgia
- Illinois
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Missouri
- Mississippi
- Montana
- North Carolina
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Puerto Rico
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
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 Jan 24, 2014.
- FDA classified it on Mar 7, 2014.
- FDA’s Enforcement Report published it on Mar 19, 2014.
- FDA terminated it on Aug 11, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Clarity Medical Systems Inc, of Pleasanton, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 3,530 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
-
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.