Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 4,851–4,900 of 8,689
- Class I
Medical Device Recall · December 20, 2024
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class I
Medical Device Recall · December 20, 2024
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002APThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class II
Medical Device Recall · December 20, 2024
Baxter Solution Set with Duo-Vent Spike, REF 2R8404Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class I
Medical Device Recall · December 20, 2024
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002APThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Class II
Medical Device Recall · December 19, 2024
8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
Ortho-Clinical Diagnostics, INc.
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product DescriThe VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
- Class II
Medical Device Recall · December 19, 2024
Ortho-Clinical Diagnostics, INc.
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher ProduThe VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
- Class II
Medical Device Recall · December 19, 2024
8MM,TENACULUM FORCEPS,IS4000¿ REF 470207Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CEDue to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
- Class II
Medical Device Recall · December 19, 2024
8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,CADIERE FORCEPS,IS4000 REF 471049Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
Ortho-Clinical Diagnostics, INc.
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higherThe VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
- Class II
Medical Device Recall · December 19, 2024
8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
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 manipuDue to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
- Class II
Medical Device Recall · December 19, 2024
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;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.
- Class II
Medical Device Recall · December 19, 2024
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,PROGRASP FORCEPS,IS4000 REF 471093Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CEScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
8MM,FORCE BIPOLAR,IS4000 REF 471405Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
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 retractioDue to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
8MM,LONG TIP FORCEPS,IS4000 REF 471048Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;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.
- Class II
Medical Device Recall · December 19, 2024
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.