Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Recalled by American Medical Systems, Inc. Due to AMS' supplier has issued a recall of certain...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact American Medical Systems, Inc. directly.
Affected Products
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.
Quantity: 184 (110 US, 74 OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About American Medical Systems, Inc.
American Medical Systems, Inc. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report