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.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IISIMPLY SALINE NASAL MIST 3.1 OZ, SKU 999801
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IIPOLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT, SKU 906131
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IIGS SALINE SOLUTION 12FL OZ, SKU 902274
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IIAT HOME MARIJUANA TEST STRIP, SKU 900752
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IINEW SKIN LIQUID BANDAGE CLEAR .3FL OZ, SKU 999417
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IIOPTI FREE REPLENISH MULTI PURPOSE 2 OZ
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IIPOLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ, SKU 900723 SUPER POLIGRIP ADH CREAM .75OZ, SKU 900085
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IIFIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IIFIRST RESPONSE 2 CT, SKU 902343
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IICURAD STRNG WATRPRF STRIP 1IN 20CT, SKU
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IITRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IIGS DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GS DENTURE CLEAN OVRNT TAB 40CT, SKU 906023
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IICLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IICURAD FIRST AID KIT, SKU 999037
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IIB L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ, SKU 999009
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IISKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IIDENTEMP ONE STEP .077OZ, SKU 902139
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IIVeriquick Pregnancy Test 2CT, SKU 903756
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IIVERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceFamily Dollar Stores, Llc.Class IICLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2022-08-24FDA-DeviceLuminex CorporationClass IIARIES SARS-CoV-2 Assay
SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.
- 2022-08-24FDA-DeviceMyolyn Inc.Class IIPower electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
- 2022-08-24FDA-DeviceAbbott Molecular, Inc.Class IIThe Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Incorrect optical calibration
- 2022-08-24FDA-DeviceASO LLCClass II(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.
The product falls apart during handling after removal from its primary packaging.
- 2022-08-24FDA-DeviceHeartware, Inc.Class IHeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
- 2022-08-17FDA-DeviceAesculap Implant Systems LLCClass IIAeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
- 2022-08-17FDA-DeviceRoche Diagnostics Operations, Inc.Class IIcobas e801 Immunoassay Analyzer
Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.
- 2022-08-17FDA-DeviceOlympus Corporation of the AmericasClass IIShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment
- 2022-08-17FDA-DeviceSpacelabs Healthcare, Inc.Class IIXhibit Telemetry Receiver, Model: 96280
Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.
- 2022-08-17FDA-DeviceGE Healthcare, LLCClass IIService manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/CT systems.
As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.
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