Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-12-27FDA-DeviceExactech, Inc.Class IIExactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceExactech, Inc.Class IIExactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceExactech, Inc.Class IIExactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceExactech, Inc.Class IIExactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceExactech, Inc.Class IIExactech Novation Hip System, Catalog Numbers: 134-36-45
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceExactech, Inc.Class IIExactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceExactech, Inc.Class IIExactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46-13
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceExactech, Inc.Class IIExactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceExactech, Inc.Class IIAcuMatch Hip System, Catalog Number 142-32-27
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DevicePhilips North America LlcClass IIThe device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
- 2023-12-27FDA-DeviceKarl Storz EndoscopyClass IIInjection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
- 2023-12-27FDA-DeviceKarl Storz EndoscopyClass IIInjection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 738758; Needle, bayonet-shaped, REF: 810505; Needle, Septum, angular, REF: 810506
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
- 2023-12-27FDA-DeviceKarl Storz EndoscopyClass IIInjection Needle, LUER-lock,0.8mm, REF: 26175PD
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
- 2023-12-27FDA-DeviceKarl Storz EndoscopyClass IIInjection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
- 2023-12-27FDA-DeviceKarl Storz EndoscopyClass IIInjection Needle, REF: 25207
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
- 2023-12-27FDA-DeviceBiomet, Inc.Class IIBiolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
- 2023-12-27FDA-DeviceBiomet, Inc.Class IIBiolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
- 2023-12-27FDA-DeviceOlympus Corporation of the AmericasClass IIACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
- 2023-12-27FDA-DevicePhysio-Control, Inc.Class IIAC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
- 2023-12-27FDA-DeviceCardioQuip, LLCClass IICardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
- 2023-12-27FDA-DeviceCardioQuip, LLCClass IICardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
- 2023-12-27FDA-DeviceVero Biotech, LLCClass IIVERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use
Cassette did not meet an 1n-process flow criterion.
- 2023-12-27FDA-DeviceInpeco S.A.Class IIRoche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions: COBASa_2.2.0, COBASa_2.3.0
Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
- 2023-12-27FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose
- 2023-12-27FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allura 9 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722026 Allura Xper FD10 722028 Allura Xper FD20 722033 Allura Xper FD10 OR Table 722035 Allura Xper FD20 OR Table 722043 Integris Allura 15 & 1
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose
- 2023-12-27FDA-DeviceFresenius Kabi USA, LLCClass IIvenix Infusion System (IIS), Large Volume Pump LVP-0004
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
- 2023-12-27FDA-DeviceResMed Ltd.Class IAirFit F30i Full Face Mask and User Guide
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
- 2023-12-27FDA-DeviceResMed Ltd.Class IAirFit F30 Full Face Mask and User Guide
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
- 2023-12-27FDA-DeviceResMed Ltd.Class IAirTouch N20 Nasal Mask and User Guide
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
- 2023-12-27FDA-DeviceResMed Ltd.Class IAirFit N20 Nasal Mask and User Guide
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
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