Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM, POTTS SCISSORS, IS4000 REF 470001
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceIntuitive Surgical, Inc.Class II8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceTornier S.A.S.Class IIStryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
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.
- 2025-01-22FDA-DeviceColoplast Manufacturing US, LLCClass IIX-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
- 2025-01-22FDA-DeviceColoplast Manufacturing US, LLCClass IIFolysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
- 2025-01-22FDA-DeviceAugustine Temperature Management, LLCClass IIAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
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".
- 2025-01-22FDA-DeviceAugustine Temperature Management, LLCClass IIAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
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".
- 2025-01-22FDA-DeviceAugustine Temperature Management, LLCClass IIHillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
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".
- 2025-01-22FDA-DeviceAugustine Temperature Management, LLCClass IIAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
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".
- 2025-01-22FDA-DeviceAugustine Temperature Management, LLCClass IIAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
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".
- 2025-01-22FDA-DeviceNOA Medical Industries IncClass IINOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.
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