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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 4281–4300 of 39,430 recalls

Class IIOngoing

KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123

Karl Storz Endoscopy

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.

Intuitive Surgical, Inc.

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM,FORCE BIPOLAR,IS4000 REF 471405

Intuitive Surgical, Inc.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.

Intuitive Surgical, Inc.

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

December 19, 2024 · DeviceView details →
Class IIOngoing

KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

Karl Storz Endoscopy

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

December 19, 2024 · DeviceView details →
Class IIOngoing

Bodor P and C series laser cutting machines

Jinan Bodor Cnc Machine Co Ltd

Non-compliant laser products

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296

Intuitive Surgical, Inc.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344

Intuitive Surgical, Inc.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

December 19, 2024 · DeviceView details →
Class IIOngoing

KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

Karl Storz Endoscopy

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

December 19, 2024 · DeviceView details →
Class IIOngoing

Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

New Medical Technologies Gmbh

During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171

Intuitive Surgical, Inc.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

December 19, 2024 · DeviceView details →
Class IIOngoing

KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

Karl Storz Endoscopy

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007

Intuitive Surgical, Inc.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM,FORCE BIPOLAR,IS4000 REF 470405

Intuitive Surgical, Inc.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344

Intuitive Surgical, Inc.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230

Intuitive Surgical, Inc.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

December 19, 2024 · DeviceView details →
Class IIOngoing

KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

Karl Storz Endoscopy

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM, POTTS SCISSORS, IS4000 REF 470001

Intuitive Surgical, Inc.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327

Intuitive Surgical, Inc.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

December 19, 2024 · DeviceView details →
Class IIOngoing

8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171

Intuitive Surgical, Inc.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

December 19, 2024 · DeviceView details →
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