Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-02-23FDA-DeviceHill-Rom, Inc.Class IILiko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
Missing bushing on Liko M220 and M230 causing wear and potential for patient falling
- 2022-02-23FDA-DeviceHill-Rom, Inc.Class IILiko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010
Missing bushing on Liko M220 and M230 causing wear and potential for patient falling
- 2022-02-23FDA-DeviceOlympus Corporation of the AmericasClass IIOER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent
- 2022-02-23FDA-DeviceTELEFLEX MEDICAL INCClass IArrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-23FDA-DeviceTELEFLEX MEDICAL INCClass I5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-23FDA-DeviceTELEFLEX MEDICAL INCClass IArrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-23FDA-DeviceTELEFLEX MEDICAL INCClass IArrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-23FDA-DeviceTELEFLEX MEDICAL INCClass IArrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-23FDA-DeviceTELEFLEX MEDICAL INCClass IArrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-23FDA-DeviceTELEFLEX MEDICAL INCClass IArrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-23FDA-DeviceVyaire MedicalClass Ibellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.
Potential cessation in ventilation can occur under specific conditions.
- 2022-02-23FDA-DeviceBASE 10 GENETICS INCClass IRNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleeve. RNAstill Molecular Transport Medium (MTM) safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing safe transport of specimens at ambient temperature from the collection site to
The product does not have 510(k) clearance.
- 2022-02-16FDA-DeviceMicrobiologics IncClass IIILYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
- 2022-02-16FDA-DeviceMicrobiologics IncClass IIIKWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
- 2022-02-16FDA-DeviceSmith & Nephew, Inc.Class IIAcufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
- 2022-02-16FDA-DeviceSynthes (USA) Products LLCClass IIUniversal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System (FRNA), and Flexible Monobloc Reamers. Instrument Handles are intended for holding instruments for manipulation during orthopedic surgery. Product No.: 03.043.001
Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.
- 2022-02-16FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICURAD REUSABLE GEL HOT/COLD PACK
The product contains natural rubber latex but the label states that it does not.
- 2022-02-16FDA-DeviceDePuy Orthopaedics, Inc.Class IIATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
- 2022-02-16FDA-DeviceDePuy Orthopaedics, Inc.Class IIATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
- 2022-02-16FDA-DeviceBecton Dickinson & Co.Class IIBD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
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