American Medical Systems recalls
American Medical Systems appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2014-12-24.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 6 |
|---|---|
| Published | 2012-11-14 to 2014-12-24 |
| By agency | FDA Device (6) |
| By classification | Class II (6) |
| By status | terminated (6) |
| Distribution named in notices | US |
Recalls
- AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195…
FDA Device · Class II · 2014-12-24 · American Medical Systems
Reason: During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sli… - AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance M…
FDA Device · Class II · 2014-12-24 · American Medical Systems
Reason: During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sli… - AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850
FDA Device · Class II · 2014-11-19 · American Medical Systems
Reason: 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 suppl… - AMS 800¿ Urinary Control System
FDA Device · Class II · 2013-05-22 · American Medical Systems
Reason: American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final prod… - AMS 800¿ Urinary Control System
FDA Device · Class II · 2013-05-22 · American Medical Systems
Reason: American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final prod… - AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS M…
FDA Device · Class II · 2012-11-14 · American Medical Systems
Reason: American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in th…