Medical DeviceNov 4, 2020
Boston Scientific Visual-ICE MRI Cryoablation System Mobile Connection Panel recall — FDA Z-0287-2021
Incorrectly installed base.
Class IIFDA: TerminatedBoston Scientific Corporation
November 2020 recalls — page 10
These records include useful source details for the selected month.
Medical DeviceNov 4, 2020
W L Gore & Associates GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System recall — FDA Z-0291-2021
When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being…
Class IIFDA: OngoingW L Gore & Associates, Inc.
Medical DeviceNov 4, 2020
Exactech Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform recall — FDA Z-0307-2021
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 4, 2020
RTI Surgical Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN recall — FDA Z-0299-2021
The Streamline Navigation System taps have experienced binding with other devices.
Class IIFDA: TerminatedRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceNov 4, 2020
GE Healthcare Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product recall — FDA Z-0306-2021
There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceNov 4, 2020
Intuitive Surgical da Vinci Surgical System, IS 4000 recall — FDA Z-0283-2021
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher…
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceNov 4, 2020
RTI Surgical Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN recall — FDA Z-0300-2021
The Streamline Navigation System taps have experienced binding with other devices.
Class IIFDA: TerminatedRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceNov 4, 2020
Microbiologics Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule recall — FDA Z-0303-2021
KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceNov 4, 2020
Pentax of 9372HD Digital Capture recall — FDA Z-0292-2021
There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur…
Class IIFDA: TerminatedPentax of America Inc.
Medical DeviceNov 4, 2020
Merge LIS recall — FDA Z-0289-2021
A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceNov 4, 2020
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A recall — FDA Z-0284-2021
The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles.…
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceNov 4, 2020
Becton Dickinson & Company Bard 3F SL PowerMidline Full Kit CE-indicated for short term recall — FDA Z-0295-2021
Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceNov 4, 2020
Battelle Memorial Institute Critical Care Decontamination System (CCDS) Compatible N95 recall — FDA Z-0309-2021
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Class IIFDA: TerminatedBattelle Memorial Institute
Medical DeviceNov 4, 2020
CME recall — FDA Z-0305-2021
The wall charger may not properly charge the infusion pump battery.
Class IIFDA: TerminatedCME America LLC
Medical DeviceNov 4, 2020
Smith & Nephew 5.5MM Arthrogarde Hip Access Cannula recall — FDA Z-0301-2021
The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
Class IIFDA: TerminatedSmith & Nephew, Inc.
FoodNov 4, 2020
Nurture Inc. dba Happy Family Happy Tot Superfoods Gluten Free Oat Bar Organic Blueberries & recall — FDA F-0067-2021
Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).
Class IIFDA: OngoingNurture Inc. dba Happy Family
FoodNov 4, 2020
Capital Seaboard Gracie's Pointe frozen raw shrimp recall — FDA F-0070-2021
Frozen raw shrimp in import alert inadvertently released for distribution.
Class IIFDA: TerminatedCapital Seaboard
FoodNov 4, 2020
Nurture Inc. dba Happy Family Happy Tot Superfoods Gluten Free Oat Bar Organic Bananas recall — FDA F-0068-2021
Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).
Class IIFDA: OngoingNurture Inc. dba Happy Family
FoodNov 4, 2020
HU PRODUCTS Primary/Retail Package labeled in part: "Hu recall — FDA F-0065-2021
Product may contain undeclared almonds.
Class IIFDA: TerminatedHU PRODUCTS
FoodNov 4, 2020
Hadson (Toko) Trading Co Eishindo brand "CUP JELLY recall — FDA F-0072-2021
Product is a choking hazard.
Class IFDA: TerminatedHadson (Toko) Trading Co., Inc.
FoodNov 4, 2020
Nurture Inc. dba Happy Family Happy Kid Gluten Free Fruit & Oat Bar Organic Blueberry & recall — FDA F-0069-2021
Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).
Class IIFDA: OngoingNurture Inc. dba Happy Family
DrugNov 4, 2020
RemedyRepack Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards recall — FDA D-0050-2021
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class IIFDA: TerminatedRemedyRepack Inc.
DrugNov 4, 2020
Jarrow Formulas N-A-C recall — FDA D-0302-2021
Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
Class IIFDA: TerminatedJarrow Formulas Inc.
VehicleNov 4, 2020
BMW control arm recall — NHTSA campaign 20V678000
BMW of North America, LLC (BMW) is recalling certain 2020 X5 sDrive40i, xDrive40i, X5 M50i, X5M, X7 xDrive40i, X7 M50i, X6 xDrive40i, X6 M50i and X6M vehicles and 2021 X5 xDrive45e…
control armBMW of North America, LLC
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.