Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 5,201–5,250 of 7,979
- Class II
Medical Device Recall · August 9, 2024
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmiasDue to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.
- Class I
Medical Device Recall · August 8, 2024
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
- Class II
Medical Device Recall · August 8, 2024
Ziehm Vision FD. Interventional fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
- Class II
Medical Device Recall · August 8, 2024
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.
- Class II
Medical Device Recall · August 8, 2024
Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
- Class II
Medical Device Recall · August 8, 2024
Fusion Pro 24, Model 17000a. A small number of Fusion Pro 24 units were released with an incorrectly placed Interlock device. As a result, the system can be operated with the front-loading door in an open position. b. Fails to comply with Class 2 designation, indicated in Part 6 of Laser Product Report. An incorrectly placed Interlock device can allow Class 4 laser radiation fields during operation.
- Class II
Medical Device Recall · August 8, 2024
Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
- Class II
Medical Device Recall · August 8, 2024
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiologicalThe National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
- Class III
Medical Device Recall · August 8, 2024
eakin Cohesive seal, small, Model Number 839002, ostomy barrier sealOn lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.
- Class II
Medical Device Recall · August 8, 2024
Ziehm Solo FD. Interventional fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
- Class II
Medical Device Recall · August 8, 2024
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
- Class I
Medical Device Recall · August 8, 2024
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
- Class II
Medical Device Recall · August 8, 2024
ViewPoint; system, imaging processing, radiologicalThe National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
- Class I
Medical Device Recall · August 8, 2024
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
- Class II
Medical Device Recall · August 8, 2024
Ziehm Vision RFD. Interventional fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
- Class II
Medical Device Recall · August 8, 2024
Ziehm Solo. Digital Mobile C-armZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
- Class II
Medical Device Recall · August 8, 2024
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision.
- Class II
Medical Device Recall · August 8, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
- Class II
Medical Device Recall · August 8, 2024
Ziehm Vision system, x-ray, tomography, computed.Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
- Class I
Medical Device Recall · August 8, 2024
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
- Class II
Medical Device Recall · August 8, 2024
Ziehm Vision R. Iterventional fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
- Class II
Medical Device Recall · August 8, 2024
Fresenius Medical Care Holdings, Inc.
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 19Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Shoulder, SESH18I; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Vaginal Delivery, ASDV25B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
IR Procedure Pack, CEAT19W; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
Fisher & Paykel Healthcare, Ltd.
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontDue to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603Products expire prior to the expiration date printed on the product labeling
- Class II
Medical Device Recall · August 7, 2024
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372Products expire prior to the expiration date printed on the product labeling
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Neuro Vascular, ANKV91A; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Day Surgery General Pack, FHGE18T; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Hand Pack, AKHD97C; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614Products expire prior to the expiration date printed on the product labeling
- Class I
Medical Device Recall · August 7, 2024
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050UExtension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Endovascular AAA Pack, ESED52B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Paracentesis Thoracente, SLPT76H; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613Products expire prior to the expiration date printed on the product labeling
- Class II
Medical Device Recall · August 7, 2024
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668Products expire prior to the expiration date printed on the product labeling
- Class II
Medical Device Recall · August 7, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
ENT, COEN27N; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003USome automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Nasal Sinus Pack, MTSN26B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374Products expire prior to the expiration date printed on the product labeling
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Arthroscopy Pack, MSKA45A; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Open Shoulder, LWOS39L; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
PACEMAKER PACK, SLCV01J; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Pacemaker, COPM11B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Endovascular AAA Pack, ESED52B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · August 7, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602Products expire prior to the expiration date printed on the product labeling