Arthex S3 Arm Sleeve Connector
Medical device recall Z-0928-2017. Published in FDA’s Enforcement Report on Jan 4, 2017.
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 Jan 4, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Florida the one state its words name
- 420 devices 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?
During use, the unit could separate un-expectantly. This failure would allow the patient’s arm to fall out of suspension during a procedure, possibly causing moderate injury to the patient. This potential defect is not apparent to the user.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
420 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
499633 499694 499274 499367 499410 499383 499479 499573 499615 499634 499695 499275 499368 499411 499384 499480 499574 499616 499635 499696 499276 499369 499412 499385 499481 499575 499617 499636 499697 499277 499370 499413 499386 499482…
Every code shown here, 1,995 characters
499633 499694 499274 499367 499410 499383 499479 499573 499615 499634 499695 499275 499368 499411 499384 499480 499574 499616 499635 499696 499276 499369 499412 499385 499481 499575 499617 499636 499697 499277 499370 499413 499386 499482 499576 499618 499637 499698 499278 499371 499414 499387 499483 499577 499619 499638 499699 499279 499372 499415 499388 499484 499578 499620 499639 499700 499280 499323 499416 499389 499485 499579 499621 499640 499701 499281 499324 499417 499390 499486 499580 499622 499641 499702 499282 499325 499418 499391 499487 499581 499623 499659 499703 499283 499326 499419 499392 499488 499582 499624 499660 499704 499284 499327 499420 499393 499471 499583 499625 499661 499705 499285 499328 499421 499394 499472 499584 499626 499662 499706 499286 499329 499422 499395 499489 499585 499627 499663 499707 499287 499330 499423 499396 499490 499586 499628 499664 499708 499288 499331 499424 499397 499491 499587 499629 499665 499709 499289 499332 499425 499440 499492 499588 499630 499666 499710 499290 499333 499426 499441 499493 499589 499552 499667 499298 499291 499334 499427 499442 499494 499590 499553 499668 499299 499292 499335 499428 499443 499495 499592 499554 499669 499300 499293 499336 499429 499444 499496 499593 499555 499671 499301 499294 499337 499430 499445 499497 499594 499556 499672 499302 499295 499338 499431 499446 499498 499595 499557 499673 499303 499296 499339 499432 499447 499499 499596 499558 499674 499304 499297 499340 499433 499448 499500 499597 499559 499675 499305 499348 499341 499434 499449 499501 499598 499560 499676 499306 499349 499342 499435 499450 499502 499599 499561 499677 499307 499350 499343 499436 499451 499503 499600 499562 499678 499308 499351 499344 499437 499452 499504 499601 499563 499679 499309 499352 499345 499438 499453 499505 499602 499564 499680 499310 499353 499346 499439 499454 499506 499603 499565 499681 499311 499354 499347 499468 499455 499507 499604 499566 499682 499312 499355 499398 499469 499456…
FDA’s list runs to 2,708 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.
US Distribution to the state of : FL
The states and territories these words name
- Florida
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Nov 23, 2016.
- FDA classified it on Dec 29, 2016.
- FDA’s Enforcement Report published it on Jan 4, 2017.
- FDA terminated it on Aug 20, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Allen Medical Systems, Inc., of Acton, MA.
- 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 2,708 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.