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All product recalls associated with SeaSpine, Inc.
Total Recalls
814
Past Year
45
Class I (Serious)
186
Most Recent
Dec 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.
SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws.
SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws.
The recalled winter gloves are black-colored and have a battery-powered heating element. The gloves included in the recall are style number 77000 (men's) in sizes S, M, L, XL, and style number 77010 (women's) in sizes S, M, L. The product name is printed on the inside cuff of the left glove.
Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.
Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.
Breakage in the welds was discovered in a section of the chair frame.
The Sun Smarties™ board skirts are peach microfiber with an embroidered flower accent and back pocket. Item number 13926 HIBI is printed on the care label inside the back of the waistband. The skirts were sold in girls' sizes 12 months to 4T. The skirts have six grommets, four on the front of the waistband and two on the back pocket.
Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.
Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significant delay and has the potential to result in a permanent injury.
This recall involves two styles of Starbucks 14-ounce Fusion Coffee Mugs. The mugs are white and have a black plastic handle, and a stainless steel base. The cups have "Starbucks Coffee" printed on a black stamp or a brown original Starbucks logo stamp.
The 2006 Line X-Fly and Line Pro model ski boards were sold in 90- and 99-centimeter lengths. The Pro model is a twin-tip ski which is turned up at both ends. "Pro 90" or "Pro 98" is printed on the tail. The X-Fly is a unidirectional ski which is turned up on one end. "Fly 90" or "Fly 99" is printed on the tail.
Mislabeled: boxes actually contained Tri-Fact needles
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
Product is misbranded; 19 gauge Schlera Plugs distributed in containers labeled as 19 gauge Trochar Canula Plugs.
The ball screw on the unit which supports the detector head (which weighs approximately 800 lbs.) could snap resulting in the detector head dropping on the patient.
No documentation to support shelf life/sterility
The uterine stop component was not included with the device.
Due to potential embrittlement of the plastic tip which may crack or separate during use.
Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use.