Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-12-18FDA-DeviceRoche Diagnostics Operations, Inc.Class IIElecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190
Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).
- 2019-12-18FDA-DeviceBoston Scientific CorporationClass IIHabib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.
- 2019-12-18FDA-DeviceBoston Scientific CorporationClass IIHabib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.
- 2019-12-18FDA-DeviceDePuy Mitek, Inc., a Johnson & Johnson Co.Class IIHealix Knotless ADV BR 5.5 Suture Anchor
Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE¿ Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
- 2019-12-18FDA-DeviceDePuy Mitek, Inc., a Johnson & Johnson Co.Class IIHealix Knotless ADV BR 4.75 Suture Anchor
Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE¿ Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
- 2019-12-18FDA-DeviceAbbott MedicalClass IIRadiofrequency Grounding Pad, REF RF-DGP-L
Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.
- 2019-12-18FDA-DeviceLivaNova USA IncClass IIVNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.
- 2019-12-18FDA-DeviceParagon 28, Inc.Class IIP28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
- 2019-12-18FDA-DeviceYoung Dental Manufacturing Co, LLCClass IIOral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Product shelf life may be shorter than that indicated on the label.
- 2019-12-18FDA-DeviceBellus MedicalClass IISKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used to soothe and calm skin (cosmetic). The SKINFUSE LIFT HG is a hydrogel wound dressing to protect against abrasion and friction during the microneedling procedure.
Cosmetic Kit was packaged with a mislabel medical product.
- 2019-12-18FDA-DeviceMedtronic Navigation, Inc.Class IIBiopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.
- 2019-12-18FDA-DeviceMedtronic Navigation, Inc.Class IIBiopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.
- 2019-12-18FDA-DeviceMedtronic Navigation, Inc.Class IIPassive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.
- 2019-12-18FDA-DeviceEthicon Endo-Surgery IncClass IILigamax 5 mm Endoscopic Multiple Clip Applier
A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.
- 2019-12-18FDA-DeviceCP Medical IncClass IICoated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Failed to meet USP minimum average value for knot pull (tensile) strength.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- 2019-12-18FDA-DeviceIntegra LifeSciences Corp.Class IIC7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
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