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All product recalls associated with Genicon, Inc..
Total Recalls
134
Past Year
7
Class I (Serious)
0
Most Recent
Sep 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Device malfunction causing the applier to jam, and clip loading failures.
Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles
The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).
Lack of CGMPs:
Lack of CGMPs:
Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
Temperature deviation did not meet release specifications
A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
The product do not meet certain internal testing specifications.
The product does not meet certain internal strength testing specifications.
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
Observed reported incidence rate for harm associated with intraoperative bleeding
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
TAP Worldwide, LLC (TAP) is recalling certain Rubicon Express aftermarket Lower Control Arms, part numbers RE4000, RE4010, and RE4050. These lower control arms have welds that may fail.