January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, POTTS SCISSORS, IS4000 REF 470001
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Tornier S.A.S. recalls Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthro
Hazard: The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.
January 22, 2025Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222,
Hazard: A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
January 22, 2025Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA612
Hazard: A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
January 22, 2025Medical DevicesFDA
Augustine Temperature Management, LLC recalls Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V;
Hazard: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
January 22, 2025Medical DevicesFDA
Augustine Temperature Management, LLC recalls Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V;
Hazard: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
January 22, 2025Medical DevicesFDA
Augustine Temperature Management, LLC recalls Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses
Hazard: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
January 22, 2025Medical DevicesFDA
Augustine Temperature Management, LLC recalls Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # W
Hazard: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
January 22, 2025Medical DevicesFDA
Augustine Temperature Management, LLC recalls Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # W
Hazard: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
January 22, 2025Medical DevicesFDA
NOA Medical Industries Inc recalls NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Hazard: Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.