Hearth Record

BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe…

Medical device recall Z-2274-2013. Published in FDA’s Enforcement Report on Oct 2, 2013.

FDA’s own record, on accessdata.fda.gov

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 Oct 2, 2013. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe may stall or stick within the syringe preventing the user from detecting a loss of resistance upon entering the epidural space.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.

1,335,885 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

510K K925902 D041521 Catalog Number: 405198 Lots 8310086 9246684 0035495 0053165 0056608 0056607 0096757 0120074 0126127 0152581 0242475 0258468 0258469 0258472 0291220 0291221 0291223 0291224 0278495 0291218 0291219 0291222 0291226…

Every code shown here, 1,618 characters

510K K925902 D041521 Catalog Number: 405198 Lots 8310086 9246684 0035495 0053165 0056608 0056607 0096757 0120074 0126127 0152581 0242475 0258468 0258469 0258472 0291220 0291221 0291223 0291224 0278495 0291218 0291219 0291222 0291226 0291227 0291228 0336391 0336393 0336396 0336400 1005321 1006136 1033177 1033178 1094304 1209634 1210646 1213990 1213993 1276782 1307383 2032802 2033712 2060835 2065940 2084318 2121011 2122467 2205098 2212313 2276066 3038272 3042376 3063436 3063440 3085498 3085001 3085003 3085005 3123462 3123246 3184092 Catalog Number 405291 Lots 0154661 0174905 0252565 0279140 0301813 0347866 1012200 1035046 1063738 1095340 1124755 1180073 1213029 1262268 1273795 1312116 1320204 1356378 2041210 2058524 2083246 2135469 2158092 2170207 2194139 2205106 2223162 2223337 2250088 2286395 2303137 2303141 2334338 2334339 2355389 2355391 3057376 3120039 Catalog Number 405807 Lots GD873422 GD874743 GD875419 GD876029 GD876912 GD879577 GD881128 GD883033 Catalog Number 405823 Lots GD877068 GD882951 GD884312 GD885491 GD886192 GD887893 GD889527 B01F223D B01F243D B01G057D B01G196D Catalog Number 406078; Lots GD876003 GD877787 GD881169 GD883017 GD883660 GD885202 GD886283 GD888677 GD890442 B01F054D B02F156D B02F178D B03F074D B03F241D Catalog number 406084 Lots B03F090D B06F326D GD875369 GD880427 GD883025 GD888255 B05G087D Catalog # 406119 Lots GD873364 GD875625 GD877878 GD879015 GD881813 GD885129 GD889782 B02F051D B02F096D B01F135D B03F222D Catalog # 406121 Lots GD887596 GD889618 Catalog # 406156 Lots GD887778 GD889733 GD889980 GD890178 B02F214D B02F292D B02G157D B03F292D B03G158D B04F238D B05F241D

Source:

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 including FL, VA, TX, NY, IL, AZ, MI, RI, NJ, SC, MO, TN, CA, MN, UT, GA, NE, OH, MD, PA, MT and internationally to Brazil, Australia, Canada, and Puerto Rico..

The states and territories these words name

21 states and territories.

Every one of them
  • Arizona
  • California
  • Florida
  • Georgia
  • Illinois
  • Maryland
  • Michigan
  • Minnesota
  • Missouri
  • Montana
  • Nebraska
  • New Jersey
  • New York
  • Ohio
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • Tennessee
  • Texas
  • Utah
  • Virginia

The words say it went outside the United States too.

Source:

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Aug 23, 2013.
  • FDA classified it on Sep 25, 2013.
  • FDA’s Enforcement Report published it on Oct 2, 2013.
  • FDA terminated it on Mar 19, 2014.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Becton Dickinson & Company, of Franklin Lakes, NJ.
  • 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.
Source:

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.”
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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