Medical DeviceJul 14, 2021
Luminex Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) recall — FDA Z-2011-2021
Potential for a false-negative result.
Class IIFDA: OngoingLuminex Corporation
Monthly breakdown
2021 recalls by month
Select a month to review the recall records reported during that period.
December 2021194 records · 4 categoriesNovember 2021210 records · 4 categoriesOctober 2021342 records · 4 categoriesSeptember 2021300 records · 4 categoriesAugust 2021279 records · 4 categoriesJuly 2021251 records · 4 categoriesJune 2021361 records · 4 categoriesMay 2021226 records · 4 categoriesApril 2021279 records · 4 categoriesMarch 2021241 records · 4 categoriesFebruary 2021320 records · 4 categoriesJanuary 2021226 records · 4 categories
2021 recalls — page 63
Records are ordered by the best available source date.
Medical DeviceJul 14, 2021
Medtronic Heart Valves Division CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L recall — FDA Z-2041-2021
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Class IIFDA: OngoingMedtronic Heart Valves Division
Medical DeviceJul 14, 2021
Luminex Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) recall — FDA Z-2010-2021
Potential for a false-negative result.
Class IIFDA: OngoingLuminex Corporation
Medical DeviceJul 14, 2021
GE Healthcare Revolution CT recall — FDA Z-2004-2021
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the…
Class IIFDA: CompletedGE Healthcare, LLC
Medical DeviceJul 14, 2021
Siemens Medical Solutions USA ARTIS pheno- angiography systems developed for single and recall — FDA Z-2029-2021
Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceJul 14, 2021
Cardinal Health 200 Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 recall — FDA Z-2037-2021
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceJul 14, 2021
Cardinal Health 200 Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N recall — FDA Z-2034-2021
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceJul 14, 2021
Siemens Healthcare Diagnostics The ADVIA Chemistry XPT Chemistry System, Siemens Material recall — FDA Z-2014-2021
ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceJul 14, 2021
Boston Scientific Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722 recall — FDA Z-2001-2021
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of…
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceJul 14, 2021
Boston Scientific VALITUDE CRT-P pacemaker, Models: a) U125 b) U128 recall — FDA Z-2002-2021
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of…
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceJul 14, 2021
Medtronic Heart Valves Division CoreValve Evolut PRO Delivery Catheter System, REF recall — FDA Z-2042-2021
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Class IIFDA: OngoingMedtronic Heart Valves Division
Medical DeviceJul 14, 2021
Luminex Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) recall — FDA Z-2008-2021
Potential for a false-negative result.
Class IIFDA: OngoingLuminex Corporation
Medical DeviceJul 14, 2021
Cardinal Health 200 Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number recall — FDA Z-2032-2021
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceJul 14, 2021
LIEBEL-FLARSHEIM COMPANY HydraVision Digital Imaging System Product ID/Reorder Number recall — FDA Z-1992-2021
Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by…
Class IIFDA: TerminatedLIEBEL-FLARSHEIM COMPANY LLC
Medical DeviceJul 14, 2021
Siemens Healthcare Diagnostics Atellica IM 1300 Analyzer - multi-component system for in recall — FDA Z-2027-2021
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceJul 14, 2021
Cardinal Health 200 Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) recall — FDA Z-2038-2021
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceJul 14, 2021
Cardinal Health 200 Sterile Femoral Angiography Drape with Single Pouch, Catalog Number recall — FDA Z-2031-2021
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceJul 14, 2021
Luminex Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) recall — FDA Z-2006-2021
Potential for a false-negative result.
Class IIFDA: OngoingLuminex Corporation
Medical DeviceJul 14, 2021
Cardinal Health 200 Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog recall — FDA Z-2035-2021
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceJul 14, 2021
Cardinal Health 200 Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia recall — FDA Z-2036-2021
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceJul 14, 2021
GE Healthcare The system is intended to produce cross-sectional images of the body by recall — FDA Z-2023-2021
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJul 14, 2021
Boston Scientific Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) recall — FDA Z-2000-2021
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of…
Class IIFDA: OngoingBoston Scientific Corporation
FoodJul 14, 2021
Greenwood Ice Cream JERSEY COOKIE MONSTER ICE CREAM 3 GALLONS recall — FDA F-0768-2021
During an FDA inspection the firm was notified that their ingredient statement does not include soy. Undeclared soy in ice cream
Class IIFDA: CompletedGreenwood Ice Cream
FoodJul 14, 2021
Beechnut Nutrition Beech-Nut brand Single Grain Rice Baby Cereal recall — FDA F-0770-2021
Product may contain elevated levels of inorganic arsenic (above 100ppb)
Class IIFDA: TerminatedBeechnut Nutrition
About the 2021 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.