Browse Device Recalls
922 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 922 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 922 FDA device recalls in WI.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 29, 2019 | Prestilix 1600X Prestilix system is a fully integrated remote controlled... | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m... | Class II | GE Healthcare, LLC |
| Mar 20, 2019 | Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose du... | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... | Class II | GE Healthcare, LLC |
| Mar 20, 2019 | Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is... | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... | Class II | GE Healthcare, LLC |
| Mar 20, 2019 | Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The ... | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... | Class II | GE Healthcare, LLC |
| Mar 20, 2019 | NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general ... | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... | Class II | GE Healthcare, LLC |
| Mar 20, 2019 | NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for gene... | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... | Class II | GE Healthcare, LLC |
| Mar 20, 2019 | NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detecto... | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... | Class II | GE Healthcare, LLC |
| Mar 20, 2019 | Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intende... | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... | Class II | GE Healthcare, LLC |
| Mar 20, 2019 | Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system i... | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... | Class II | GE Healthcare, LLC |
| Mar 20, 2019 | NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medica... | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... | Class II | GE Healthcare, LLC |
| Mar 20, 2019 | NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Disco... | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... | Class II | GE Healthcare, LLC |
| Mar 19, 2019 | AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, ... | The outer seam of the coil, closest to the system cable, may separate and expose the porous mater... | Class II | GE Healthcare, LLC |
| Mar 15, 2019 | Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating f... | There is a potential for loss of the x-ray imaging function when the user changes field of view (... | Class II | GE Healthcare, LLC |
| Mar 15, 2019 | Innova IGS 630, Angiographic X-Ray, s5i system option used in generating flu... | There is a potential for loss of the x-ray imaging function when the user changes field of view (... | Class II | GE Healthcare, LLC |
| Mar 15, 2019 | Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat... | The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack o... | Class I | GE Healthcare, LLC |
| Mar 15, 2019 | Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat i... | The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack o... | Class I | GE Healthcare, LLC |
| Mar 15, 2019 | Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating flu... | There is a potential for loss of the x-ray imaging function when the user changes field of view (... | Class II | GE Healthcare, LLC |
| Feb 22, 2019 | Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ... | The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduc... | Class III | GE Healthcare, LLC |
| Feb 12, 2019 | Discovery IQ Product Usage: The systems are intended for head and whole b... | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | Class II | GE Healthcare, LLC |
| Feb 12, 2019 | Discovery PET/CT 710 Product Usage: The systems are intended for head and... | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | Class II | GE Healthcare, LLC |
| Feb 12, 2019 | Optima PET/CT 560, 560FX Product Usage: The systems are intended for head... | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | Class II | GE Healthcare, LLC |
| Feb 12, 2019 | Discovery PET/CT 610 Product Usage: The systems are intended for head and... | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | Class II | GE Healthcare, LLC |
| Feb 12, 2019 | Discovery Ml Product Usage: The systems are intended for head and whole ... | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | Class II | GE Healthcare, LLC |
| Feb 12, 2019 | Discovery Ml DR Product Usage: The systems are intended for head and whol... | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | Class II | GE Healthcare, LLC |
| Jan 19, 2019 | Revolution CT scanners Product Usage: The system is intended for head, wh... | Additional low dose radiation exposure. | Class II | GE Healthcare, LLC |
| Dec 28, 2018 | GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model B... | Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when u... | Class II | GE Healthcare, LLC |
| Dec 20, 2018 | The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DC... | Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds... | Class II | Merge Healthcare, Inc. |
| Dec 20, 2018 | GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Uni... | When switching back & forth between multiple UV instances in the Windows taskbar, the patient im... | Class II | GE Healthcare, LLC |
| Dec 11, 2018 | U by Kotex¿ Sleek¿, Regular Tampons, 34 Count | Potential for tampon to come apart upon removal. | Class II | Kimberly-Clark Corporation |
| Dec 11, 2018 | U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack | Potential for tampon to come apart upon removal. | Class II | Kimberly-Clark Corporation |
| Dec 11, 2018 | U by Kotex¿ Sleek¿, Regular Tampons, 18 Count | Potential for tampon to come apart upon removal. | Class II | Kimberly-Clark Corporation |
| Dec 11, 2018 | U by Kotex¿ Sleek¿, Regular Tampons, 3 Count | Potential for tampon to come apart upon removal. | Class II | Kimberly-Clark Corporation |
| Nov 30, 2018 | System, Tomography Computed Emmission | GE Healthcare has identified that a small number of Nuclear Medicine systems are operating withou... | Class II | GE Healthcare, LLC |
| Nov 30, 2018 | System, Tomography Computed Emmission | GE Healthcare has identified that a small number of Nuclear Medicine systems are operating withou... | Class II | GE Healthcare, LLC |
| Nov 15, 2018 | Various GE Magnetic Resonance System on-site software version Product Usag... | Possible incorrect software version loaded. | Class II | GE Healthcare, LLC |
| Nov 9, 2018 | Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, ... | Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and ... | Class II | GE Healthcare, LLC |
| Oct 11, 2018 | Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical im... | Synchronization failure | Class II | GE Healthcare, LLC |
| Oct 11, 2018 | Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundatio... | Synchronization failure | Class II | GE Healthcare, LLC |
| Oct 5, 2018 | GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066... | The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. ... | Class I | GE Healthcare, LLC |
| Oct 3, 2018 | SIGNA Architect system Product Usage: The Signa Architect system is a who... | A small area on the bore surface, which is normally accessible to the patient, can get warm enoug... | Class II | GE Medical Systems, LLC |
| Sep 27, 2018 | Aisys CS2 Anesthesia System. Sold under the following product names: AISYS,... | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breath... | Class II | GE Healthcare, LLC |
| Sep 27, 2018 | Touchscreen display kit. Sold under the following product names: TOUCHSCREE... | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breath... | Class II | GE Healthcare, LLC |
| Sep 27, 2018 | Aisys Anesthesia System. Sold under the following product names: AISYS, AIS... | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breath... | Class II | GE Healthcare, LLC |
| Sep 26, 2018 | CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indic... | A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-l... | Class II | Accuray Incorporated |
| Sep 25, 2018 | Panda Wall Mount warmer. Infant radiant warmer | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Panda iRes Infant Radiant Warmer. Device sold under the following product nam... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Giraffe Warmer. Device sold under the following product names: Giraffe Warmer... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the follow... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Panda Freestanding Warmer. Device sold under the following product names: Pa... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Giraffe Incubator Carestation. Neonatal incubator. Device sold under the fol... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.