Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16
Medical device recall Z-0004-2013. Published in FDA’s Enforcement Report on Oct 10, 2012.
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 10, 2012. 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
- 420cases (= 4,200 boxes) 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?
The firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coud¿-tip catheters while the actual contents are M16Fr male, 16Fr, straight-tip catheters with the pouch and the case box labeled as M16Fr male, 16Fr, straight-tip catheters.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter” device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud¿-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
420cases (= 4,200 boxes), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Total affected product: M16, Lot 120425: 420 cases = 4,200 boxes = 126,000 each. 2017.03 is shown on the product labeling as the expiry date for the product, 4 years and 11 months from the date of packaging. The product, M16, is identified…
Every code shown here, 1,461 characters
Total affected product: M16, Lot 120425: 420 cases = 4,200 boxes = 126,000 each. 2017.03 is shown on the product labeling as the expiry date for the product, 4 years and 11 months from the date of packaging. The product, M16, is identified with the following UPC Codes for the individual pouches, intermediate boxes and case labels: ¿ Pouch Label UPC (M16) = *+M405M16 ¿ Box Label UPC (M16) = *+M405M163I* “ Case Label UPC (M16) = *+M405M165K* Explanation of Lot Number: The lot number represents a planned packaging date of a set of work orders for various products, in the format YYMMDD at the contract manufacturers facility. At the order planning stage, the packaging date is estimated (based on production cycle time and pre-printed box delivery) and assigned to each work order The lot number represents a planned packaging date of a set of work orders for various products, in the format YYMMDD at the contract manufacturers facility. At the order planning stage, the packaging date is estimated (based on production cycle time and pre-printed box delivery) and assigned to each work order scheduled for packaging on this estimated date. Therefore, one lot number may be assigned to multiple catalog numbers. The lot number 120425 was assigned to both M16 and M16C products by the scheduling department Actual packaging of the M16 occurred from 23 May 2012 through 25 May 2012. Actual packaging of the M16C occurred from 19 May through 21 May 2012.
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.
Nationwide Distribution
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.
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 Sep 19, 2012.
- FDA classified it on Oct 2, 2012.
- FDA’s Enforcement Report published it on Oct 10, 2012.
- FDA terminated it on Feb 7, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cure Medical LLC, of Newport Beach, 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.”
- 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.