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.
- 2022-08-10FDA-DeviceMALVERN PANALYTICAL LTDClass IINanoSight NS300
Product found to not comply to Class 1 Laser safety requirement.
- 2022-08-10FDA-DeviceNorth American DiagnosticsClass ISARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.
- 2022-08-03FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
- 2022-08-03FDA-DeviceMeridian Bioscience IncClass IIRevogene, Catalog no. 610210. IVD test instrument
When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns.
- 2022-08-03FDA-DeviceStryker InstrumentsClass IIStryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.
- 2022-08-03FDA-DeviceMEDLINE INDUSTRIES, LP - SPTClass IIMEDLINE INDUSTRIES, LP - SPT — Kits contain leaking bottles of isopropyl alcohol
Kits contain leaking bottles of isopropyl alcohol
- 2022-08-03FDA-DeviceMEDLINE INDUSTRIES, LP - SPTClass IIMedline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog Number: Model Numbers: a.DYNJ0397191V, b. DYKMBNDL138, c. DYNJ907374, d. DYKMBNDL40A, e. DYNJ908260, f. DYNJ21243M, g. DYNJ904818D, DYNJ905194, DYNJ904040D, DYNJ904040F, DYNJ904818C, DYNJ905753A, h. DYNJ0101287I,
Kits contain leaking bottles of isopropyl alcohol
- 2022-08-03FDA-DeviceMEDLINE INDUSTRIES, LP - SPTClass IIMedline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131
Kits contain leaking bottles of isopropyl alcohol
- 2022-08-03FDA-DeviceMEDLINE INDUSTRIES, LP - SPTClass IIMedline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i. EVLP Pack/Kit, j. GENERAL PURPOSE CV, k. GENERAL PURPOSE CV, l. KIT GERMANTOWN CABG, m. KIT GERMANTOWN CABG, n. DENTAL RESTORATIONS, o. ALCOHOL PREP PACK, p. ALCOHOL PREP PACK, q. MATRIXECTOMY PACK-LF Model/Catalog Number:
Kits contain leaking bottles of isopropyl alcohol
- 2022-08-03FDA-DeviceMEDLINE INDUSTRIES, LP - SPTClass IIBrand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
Kits contain leaking bottles of isopropyl alcohol
- 2022-08-03FDA-DeviceMEDLINE INDUSTRIES, LP - SPTClass IIMedline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
Kits contain leaking bottles of isopropyl alcohol
- 2022-08-03FDA-DeviceMEDLINE INDUSTRIES, LP - SPTClass IIMedline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860A
Kits contain leaking bottles of isopropyl alcohol
- 2022-08-03FDA-DeviceMEDLINE INDUSTRIES, LP - SPTClass IIMedline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEART MHS, Model Number DYNJ905394B, g. OPEN HEART WPH, Model Number DYNJ908168 Model/Catalog Number: Model Numbers: a. CDS984642, b. DYNJ902880J, c. DYNJ902880K, d. DYNJ904831F, e. DYNJ905394A, f. DYNJ905394B, g.
Kits contain leaking bottles of isopropyl alcohol
- 2022-08-03FDA-DeviceSIGHT DIAGNOSTICS LTDClass IISight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.
- 2022-08-03FDA-DeviceParagon 28, Inc.Class IIHammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Due to Titanium plasma coating not present implant.
- 2022-08-03FDA-DeviceCovidien LlcClass IITruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
- 2022-08-03FDA-DeviceGE Healthcare, LLCClass IICentricity PACS Software Version 7.0 SP0.0.4.7
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
- 2022-08-03FDA-DeviceZeiss, Carl IncClass IIIZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
- 2022-08-03FDA-DeviceFresenius Medical Care Holdings, Inc.Class IIAquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock
- 2022-08-03FDA-DeviceFresenius Medical Care Holdings, Inc.Class IIAquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock
- 2022-08-03FDA-DeviceNordicNeuroLab ASClass IInordicBrainEX, software versions 2.21 through 2.3.10
When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.
- 2022-08-03FDA-DeviceTouch US LlcClass IIetouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Device was marketed without FDA 510(k) clearance or a PMA.
- 2022-08-03FDA-DeviceIntuitive Surgical, Inc.Class IIDa Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
- 2022-08-03FDA-DeviceIntuitive Surgical, Inc.Class IIDa Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
- 2022-08-03FDA-DeviceParagon 28, Inc.Class IIParagon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
- 2022-08-03FDA-DeviceDavol, Inc.Class IIX-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
The device may potentially cause a fire, leading to a safety risk.
- 2022-08-03FDA-DeviceAbbott LaboratoriesClass IIREF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
- 2022-08-03FDA-DeviceAbbott LaboratoriesClass IIREF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
- 2022-08-03FDA-DeviceAbbott LaboratoriesClass IIREF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
- 2022-08-03FDA-DeviceNuVasive IncClass IIDescription/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc Size 3, Ht 5/LG-5; Simplify Disc Size 3, Ht 5, 5/LG-5L; Simplify Disc Size 3, Ht 6/LG-6; Simplify Disc Size 3, Ht 6, 5/LG-6L
Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.
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