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.
- 2024-10-02FDA-DevicePhilips North AmericaClass IIIntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.
- 2024-10-02FDA-DeviceHologic IncClass IISelenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS 3. ASY-17219 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS 4. ASY-17220 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3
Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis
- 2024-10-02FDA-DeviceBecton Dickinson & Co.Class IIBD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
- 2024-10-02FDA-DeviceBecton Dickinson & Co.Class IIBD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 443624
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
- 2024-10-02FDA-DeviceWaldemar Link GmbH & Co. KG (Corp. Hq.)Class IILINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIPacemaker, COPM11B; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IICysto, FTCY03L; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IINasal Sinus Pack, MTSN26B; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIENT, COEN27N; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIEssentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IICath Lab Pack, CECL02P; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIVaginal Delivery, ASDV25B; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIHand Pack, AKHD97C; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IINeuro Vascular, ANKV91A; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIIR Procedure Pack, CEAT19W; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIParacentesis Thoracente, SLPT76H; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIBilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIShoulder, SESH18I; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIDay Surgery General Pack, FHGE18T; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIOpen Shoulder, LWOS39L; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIArthroscopy Pack, MSKA45A; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIEndovascular AAA Pack, ESED52B; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIEndovascular AAA Pack, ESED52B; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceAmerican Contract Systems, Inc.Class IIPACEMAKER PACK, SLCV01J; Medical convenience kit
ACS 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.
- 2024-10-02FDA-DeviceKarl Storz EndoscopyClass IIKarl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-10-02FDA-DeviceKarl Storz EndoscopyClass IIKarl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-10-02FDA-DeviceKarl Storz EndoscopyClass IIKarl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-10-02FDA-DeviceKarl Storz EndoscopyClass IIKarl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-10-02FDA-DeviceKarl Storz EndoscopyClass IIKarl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-10-02FDA-DeviceKarl Storz EndoscopyClass IIKarl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
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