Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-10-19FDA-DeviceBaxter Healthcare CorporationClass IIPrismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
- 2022-10-19FDA-DeviceBaxter Healthcare CorporationClass IIPrismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
- 2022-10-19FDA-DeviceLUMINOSTICS, INC dba CLIP HEALTHClass IIClip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.
- 2022-10-19FDA-DeviceSteris CorporationClass IIHu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard.
- 2022-10-19FDA-DeviceOlympus Corporation of the AmericasClass IIBerkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters which were not designed for use with the VC-10, which can lead to serious injuries as it does not fit properly with the VC-10.
- 2022-10-19FDA-DeviceAmerican Contract Systems, Inc.Class IICOVID Test Kit Nonsterile
Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIHobbs Medical Polypectomy Snare Catalog Number: 4575-OLY
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIHobbs Medical Polypectomy Snare Catalog Number: 4565-OLY
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIHobbs Medical Polypectomy Snare Catalog Number: 4563-OLY
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIHobbs Medical Polypectomy Snare Catalog Number: 7202
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Catalog Number: 6584
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Catalog Number: 6582
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Catalog Number: 6568
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Catalog Number: 6567
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Catalog Number: 6566
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Catalog Number: 6562
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Catalog Number: 6548
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Catalog Number: 6544
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Catalog Number: 6535
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Catalog Number: 6534
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Catalog Number: 6533
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Kit Catalog Number: 6352
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-19FDA-DeviceHobbs Medical, Inc.Class IIFreeman Pancreatic Flexi-Stent Kit Catalog Number: 6351
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
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