Medical DeviceApr 6, 2022
Carefusion 2200 (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 recall — FDA Z-0833-2022
The finished device package did not contain the IFU.
Class IIFDA: TerminatedCarefusion 2200 Inc.
Monthly breakdown
2022 recalls by month
Select a month to review the recall records reported during that period.
December 2022318 records · 4 categoriesNovember 2022270 records · 4 categoriesOctober 2022288 records · 4 categoriesSeptember 2022318 records · 4 categoriesAugust 2022293 records · 4 categoriesJuly 2022334 records · 4 categoriesJune 2022348 records · 4 categoriesMay 2022227 records · 4 categoriesApril 2022205 records · 4 categoriesMarch 2022449 records · 4 categoriesFebruary 2022237 records · 4 categoriesJanuary 2022296 records · 4 categories
2022 recalls — page 108
Records are ordered by the best available source date.
Medical DeviceApr 6, 2022
Baxter Healthcare Liko Universal Twinbar 670 QRH, an accessory that can be used together recall — FDA Z-0829-2022
An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceApr 6, 2022
RAYSEARCH LABORATORIES AB TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A recall — FDA Z-0848-2022
If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control…
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceApr 6, 2022
RAYSEARCH LABORATORIES AB RayStation/RayPlan versions 4 - 11A, including service packs recall — FDA Z-0849-2022
An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The…
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceApr 6, 2022
Human Care USA Hanger-Bar 2P 45cm recall — FDA Z-0851-2022
The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw…
Class IIFDA: OngoingHuman Care USA, Inc.
Medical DeviceApr 6, 2022
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # recall — FDA Z-0830-2022
Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 6, 2022
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) recall — FDA Z-0827-2022
Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle…
Class IIFDA: OngoingMevion Medical Systems, Inc.
Medical DeviceApr 6, 2022
Avanos Medical BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement recall — FDA Z-0845-2022
Product was distributed with incorrect expiration date.
Class IIFDA: TerminatedAvanos Medical, Inc.
Medical DeviceApr 6, 2022
Baxter Healthcare MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482 recall — FDA Z-0831-2022
Devices distributed lacked regulatory clearance.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceApr 6, 2022
Microbiologics Pneumonia (33 Targets) Control Panel, unassayed quality control material recall — FDA Z-0844-2022
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceApr 6, 2022
Roche Molecular Systems cobas LiatSystem, respiratory virus panel nucleic acid assay system recall — FDA Z-0828-2022
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B…
Class IIFDA: OngoingRoche Molecular Systems, Inc.
Medical DeviceApr 6, 2022
InfuTronix Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number recall — FDA Z-0832-2022
An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.
Class IIFDA: OngoingInfuTronix LLC
Medical DeviceApr 6, 2022
Edwards Lifesciences FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10 recall — FDA Z-0835-2022
The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite…
Class IIFDA: OngoingEdwards Lifesciences, LLC
Medical DeviceApr 6, 2022
Howmedica Osteonics Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm recall — FDA Z-0843-2022
Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
Class IIFDA: OngoingHowmedica Osteonics Corp.
Medical DeviceApr 6, 2022
Avanos Medical BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French recall — FDA Z-0847-2022
Product was distributed with incorrect expiration date.
Class IIFDA: TerminatedAvanos Medical, Inc.
Medical DeviceApr 6, 2022
Edwards Lifesciences FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents recall — FDA Z-0834-2022
The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite…
Class IIFDA: OngoingEdwards Lifesciences, LLC
Medical DeviceApr 6, 2022
Human Care USA Hanger-Bar 2P 45cm recall — FDA Z-0852-2022
The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw…
Class IIFDA: OngoingHuman Care USA, Inc.
Medical DeviceApr 6, 2022
Avanos Medical BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French recall — FDA Z-0846-2022
Product was distributed with incorrect expiration date.
Class IIFDA: TerminatedAvanos Medical, Inc.
Medical DeviceApr 6, 2022
Meridian Bioscience Revogene, For In Vitro Diagnostic use in performing nucleic acid testing recall — FDA Z-0836-2022
The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.
Class IIFDA: OngoingMeridian Bioscience Inc.
FoodApr 6, 2022
Tova Industries Carbquik Mug Cake Double Chocolate Chunk, Net Wt recall — FDA F-0915-2022
Undeclared Allergen- Milk
Class IFDA: TerminatedTova Industries Inc.
FoodApr 6, 2022
Cavendish Farms 42.3 recall — FDA F-0959-2022
Undeclared barley and wheat flour
Class IFDA: TerminatedCavendish Farms
FoodApr 6, 2022
Fairmont Foods Schwan's Spinach & Artichoke Dip recall — FDA F-0909-2022
Cartons of Spinach Artichoke Dip may contain Chicken & Broccoli.
Class IIFDA: TerminatedFairmont Foods Inc.
FoodApr 6, 2022
Laura Chenel's Chevre St recall — FDA F-0912-2022
Undeclared Egg.
Class IFDA: TerminatedLaura Chenel's Chevre, Inc.
FoodApr 6, 2022
Jan Fruits Taiwan Best Quality Enoki Mushrooms recall — FDA F-0913-2022
California Department of Public Health sampled product and results showed the presence of Listeria monocytogenes.
Class IFDA: TerminatedJan Fruits, Inc.
About the 2022 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.