Medical DeviceOct 20, 2021
Philips recall — FDA Z-0078-2022
Customers were not notified of previous recalls associated with various defibrillator models.
Class IIFDA: OngoingPhilips North America LLC
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 22
Records are ordered by the best available source date.
Medical DeviceOct 20, 2021
Beckman Coulter Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K recall — FDA Z-0117-2022
Missing splash guard which may expose users to hazardous materials. .
Class IIFDA: OngoingBeckman Coulter Inc.
Medical DeviceOct 20, 2021
Uoc Usa United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 recall — FDA Z-0110-2022
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
Class IIFDA: TerminatedUoc Usa Inc.
Medical DeviceOct 20, 2021
Abbott Molecular Alinity m Resp-4-Plex AMP Kit recall — FDA Z-0005-2022
There is a potential for false positive results.
Class IFDA: TerminatedAbbott Molecular, Inc.
Medical DeviceOct 20, 2021
Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with recall — FDA Z-0112-2022
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Class IIFDA: TerminatedFlower Orthopedics Corporation
Medical DeviceOct 20, 2021
Draeger Medical Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the recall — FDA Z-0108-2022
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Class IIFDA: OngoingDraeger Medical, Inc.
Medical DeviceOct 20, 2021
Inpeco S.A FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) recall — FDA Z-0087-2022
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may…
Class IIFDA: OngoingInpeco S.A.
Medical DeviceOct 20, 2021
Philips recall — FDA Z-0079-2022
Customers were not notified of previous recalls associated with various defibrillator models.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceOct 20, 2021
Abbott Molecular Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 recall — FDA Z-0006-2022
There is a potential for false positive results.
Class IFDA: TerminatedAbbott Molecular, Inc.
Medical DeviceOct 20, 2021
National Distribution & Contracting ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel recall — FDA Z-0067-2022
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Class IFDA: OngoingNational Distribution & Contracting Inc.
Medical DeviceOct 20, 2021
W L Gore & Associates Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF recall — FDA Z-0077-2022
Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
Class IIFDA: OngoingW L Gore & Associates, Inc.
Medical DeviceOct 20, 2021
Red Medical Supplies EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. recall — FDA Z-0090-2022
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further…
Class IFDA: OngoingRed Medical Supplies
Medical DeviceOct 20, 2021
Red Medical Supplies EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. recall — FDA Z-0089-2022
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further…
Class IFDA: OngoingRed Medical Supplies
Medical DeviceOct 20, 2021
Abbott Molecular Alinity m SARS-CoV-2 Amp Kit recall — FDA Z-0004-2022
There is a potential for false positive results.
Class IFDA: TerminatedAbbott Molecular, Inc.
Medical DeviceOct 20, 2021
Abbott Molecular Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex recall — FDA Z-0008-2022
There is a potential for false positive results.
Class IFDA: TerminatedAbbott Molecular, Inc.
Medical DeviceOct 20, 2021
Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with recall — FDA Z-0114-2022
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Class IIFDA: TerminatedFlower Orthopedics Corporation
Medical DeviceOct 20, 2021
Intuitive Surgical Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 recall — FDA Z-0106-2022
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceOct 20, 2021
Red Medical Supplies EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. recall — FDA Z-0088-2022
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further…
Class IFDA: OngoingRed Medical Supplies
Medical DeviceOct 20, 2021
BioMerieux SA MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System recall — FDA Z-0084-2022
Under certain conditions, there is a risk for a false negative result.
Class IIFDA: TerminatedBioMerieux SA
Medical DeviceOct 20, 2021
K2M Chesapeake Anterior Lumbar (AL) Removal Tool recall — FDA Z-0104-2022
Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal…
Class IIFDA: TerminatedK2M, Inc.
Medical DeviceOct 20, 2021
Draeger Medical Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for recall — FDA Z-0109-2022
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Class IIFDA: OngoingDraeger Medical, Inc.
Medical DeviceOct 20, 2021
Medtronic Sofamor Danek USA Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface recall — FDA Z-0085-2022
Engraving on implants may not match what is listed on the pouch labels.
Class IIFDA: TerminatedMedtronic Sofamor Danek USA Inc.
Medical DeviceOct 20, 2021
Elekta Medical Linear Accelerator (EMLA), configured as follows: a recall — FDA Z-0116-2022
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the…
Class IIFDA: TerminatedElekta, Inc.
Medical DeviceOct 20, 2021
Roche Molecular Systems cobas EGFR Mutation Test v2-Somatic gene mutation detection system recall — FDA Z-0083-2022
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
Class IIFDA: OngoingRoche Molecular Systems, Inc.
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.