Medical device recalls
38750 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-03-30FDA-DeviceCytocell Ltd.Class IIICytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is 2022-02 and not 2023-05 as shown on the outer label.
- 2022-03-30FDA-DeviceAce Surgical Supply Co., Inc.Class IINuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
- 2022-03-30FDA-DeviceDollar Tree Distribution, Inc.Class IIMedical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. The general categories of products, but are limited to these products, includes: feminine hygiene products, surgical masks, contact lens cleaning solutions, bandages, nasal care products
Potential exposure to rodents and rodent activity in the distribution center.
- 2022-03-30FDA-DeviceBaxter Healthcare CorporationClass IICompella Therapy Air Supply Unit
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
- 2022-03-30FDA-DeviceBaxter Healthcare CorporationClass IICompella Bariatric Bed System
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
- 2022-03-30FDA-DeviceB Braun Medical IncClass IIPERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
- 2022-03-30FDA-DeviceIntegra LifeSciences Corp.Class IICodman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Part Number: 826616
Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
- 2022-03-30FDA-DeviceIntegra LifeSciences Corp.Class IICodman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Product umber: 826614
Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
- 2022-03-30FDA-DeviceCytocell Ltd.Class IIITCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
May show unexpected locus specific signals in addition to those at 14q32.
- 2022-03-30FDA-DeviceOutset Medical, Inc.Class IIOutset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
- 2022-03-30FDA-DeviceBiomet, Inc.Class IIBIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 829032170, 3.5X140MM DRILL], [ALPS Tap, Item # 824150170, 3.5X140MM CORTICAL TAP], [ALPS Guide Pin, Item # 829516150, 1.6X150MM BAYONET TIP GUIDE PIN], [ALPS Guide Pin, Item # 829516151, 1.6X150MM THREADED TIP
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
- 2022-03-30FDA-DeviceBiomet, Inc.Class IIBIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
- 2022-03-30FDA-DeviceBiomet, Inc.Class IIBIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
- 2022-03-30FDA-DeviceBiomet, Inc.Class IIBIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
- 2022-03-30FDA-DevicePhilips Respironics, Inc.Class ITrilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.
- 2022-03-30FDA-DevicePhilips HealthcareClass IIAzurion systems with software release R2.0.x
In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.
- 2022-03-23FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
- 2022-03-23FDA-DeviceBio-Rad Laboratories, Inc.Class IIBioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
- 2022-03-23FDA-DeviceBio-Rad Laboratories, Inc.Class IIBioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
- 2022-03-23FDA-DeviceCellEra LLCClass III20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
- 2022-03-23FDA-DeviceCellEra LLCClass III20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
- 2022-03-23FDA-DeviceCellEra LLCClass III20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
- 2022-03-23FDA-DeviceCellEra LLCClass III20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
- 2022-03-23FDA-DeviceCellEra LLCClass III20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
- 2022-03-23FDA-DeviceBard Peripheral Vascular IncClass IISAFE-T PLUS ATRAUMATIC ADULT LP TRAY
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
- 2022-03-23FDA-DeviceBard Peripheral Vascular IncClass IILUMBAR PUNCTURE DRUG FREE TRAY 22G
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
- 2022-03-23FDA-DeviceBard Peripheral Vascular IncClass IIATRAUMATIC ADULT LUMBAR PUNCTURE TRAY
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
- 2022-03-23FDA-DeviceBard Peripheral Vascular IncClass IISAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
- 2022-03-23FDA-DeviceBard Peripheral Vascular IncClass IILUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
- 2022-03-23FDA-DeviceBard Peripheral Vascular IncClass IILUMBAR PUNCTURE TRAY ADULT 18G X 3.5
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
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