AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850
Medical device recall Z-0209-2015. Published in FDA’s Enforcement Report on Nov 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 Nov 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 24 states named
- 184 (110 US, 74 OUS) 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?
AMS’ supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.
184 (110 US, 74 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Number 861912018 861914016 862631001 862639018 863952005 863960024 863962007 865584018 865585013 865593007 865869024 865882006 867705012 868952010 868961016 868962022 868964021 869672008 869673021 869683007 870935011 870935017…
Every code shown here, 1,850 characters
Lot Number 861912018 861914016 862631001 862639018 863952005 863960024 863962007 865584018 865585013 865593007 865869024 865882006 867705012 868952010 868961016 868962022 868964021 869672008 869673021 869683007 870935011 870935017 870936016 870936023 870937001 870938022 870940022 871927006 871927014 871930002 873243013 873243015 873247017 873253025 873944005 873945017 873946003 873949005 873950009 873951024 873952024 875055017 875060017 875060024 876016019 876025002 877253005 877259010 878159022 878160012 878162016 878164009 878165016 878168017 878168021 878975023 880215004 880217014 881145009 881146023 881149014 881150018 881152025 882234015 882236002 882239002 882240012 882241016 882243015 882245014 883312010 883313020 883315019 883319013 883319014 883319015 884416007 884416024 884420017 884422015 884422018 884423025 885166007 885166024 885170004 885170022 886256007 886256021 886257022 886260022 886260024 886260025 886261024 886262010 886263002 886263017 886264010 886264024 886848011 886848012 886849016 886855001 886855019 886858004 886858011 886858014 887908021 887909002 887909003 887909008 887910017 887912005 887912006 887915009 887917021 888755008 888755012 888758013 888762005 888762015 889654010 889656003 889656005 889656006 889656023 889657013 889657014 890573015 890573017 890576003 890577015 890578013 890579011 890579016 890580017 890581001 890581002 890581003 890581004 890581005 890581006 890581007 890581018 890581024 890582011 890582012 890582013 891506011 891506012 891507012 891507014 891507021 891508002 891508019 891508020 891508021 891509005 891509006 891510011 891511001 891511002 891513002 891513003 891513024 891515003 891516015 892497013 892497014 892498002 892501001 892501002 892501003 892501004 892501012 892501016 892501017 892501018 892501019 892501020 892501021 892501022 892501023 892501024 892501025
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 US (nationwide) including PR and the states of AL. AZ. AR, CA, CO, CT, IL, IN, KS, KY, MD, MA,MI, MN, MO, NY,NC, OH,OR, TN, TX, VA, and WA, and the countries of ARGENTINA, AUSTRALIA, BRAZIL, CANDA, GERMANY, FRANCE, GREAT BRITAIN, LEBANON, PANAMA, SOLOMON ISLANDS, SWEDEN, and COLOMBIA.
The states and territories these words name
24 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- North Carolina
- New York
- Ohio
- Oregon
- Puerto Rico
- Tennessee
- Texas
- Virginia
- Washington
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 Oct 10, 2014.
- FDA classified it on Nov 13, 2014.
- FDA’s Enforcement Report published it on Nov 19, 2014.
- FDA terminated it on Sep 28, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- American Medical Systems, Inc., of Minnetonka, MN.
- 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.