Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet… Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet… Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZEISS 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. Class IIIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 3, 2022ClassClass IIIStatusTerminatedWhereNationwide, and New York named
- Medical device recall Centricity 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. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedAug 3, 2022ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Nevada, Ohio, Pennsylvania and Washington named
- Medical device recall TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine… Electrical component failure within the control unit. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement Report15 statesnamed in where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereArizona, California, Colorado, Illinois, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New York, Oklahoma, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile) Due to Titanium plasma coating not present implant. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Georgia, Illinois and Kentucky named
- Medical device recall Sight OLO, Automated Hematology Analyzer 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… Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Idaho, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Medline Convenience kits labeled as follows: a Kits contain leaking bottles of isopropyl alcohol Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline convenience kits: a Kits contain leaking bottles of isopropyl alcohol Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline convenience kits labeled as: a Kits contain leaking bottles of isopropyl alcohol Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Kits contain leaking bottles of isopropyl alcohol Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits labeled as: a Kits contain leaking bottles of isopropyl alcohol Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits labeled as: a Kits contain leaking bottles of isopropyl alcohol Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Custom procedural kits labeled as follows: a Kits contain leaking bottles of isopropyl alcohol Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FDA recall Z-1477-2022 Kits contain leaking bottles of isopropyl alcohol Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker 2.3mm Tapered Router There is a potential for the core diameter to be undersized, which may lead to the router breaking. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Iowa, Michigan, Missouri, North Carolina, New Mexico, Ohio, Texas and Virginia named
- Medical device recall Revogene, 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,… Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) Manufacturing error that may have resulted in a cathode component being out of specification. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide, and California and Indiana named
- Medical device recall Trevo Trak 21 Microcatheter Microcatheter product label on the carton is missing the microcatheter product drawing/illustration. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, District of Columbia, Florida, Georgia, Illinois, New Hampshire, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SX-One MicroKnife Potential of dull blade Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Indiana, Kansas, Maryland, Michigan, Minnesota, Montana, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming named
- Medical device recall Hobbs Medical Polypectomy Snare During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNorth Carolina, Texas and Washington
- Medical device recall GE Healthcare Aisys CS2 Anesthesia System There is a potential reversal of the O2 and air cylinder pressure transducer connections. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of… The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. Class IIIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 27, 2022ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida, Louisiana, Massachusetts, Minnesota, New Jersey, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Wisconsin named
- Medical device recall ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 27, 2022ClassClass IIStatusCompletedWhereNationwide, and Alabama, Arizona, California, Colorado, Idaho, Illinois, Louisiana, Massachusetts, Missouri, North Carolina, Oklahoma, Texas and Wisconsin named
- Medical device recall GreenLight HPSEA Laser Fibers, UPN 0010-2092 Several complaints were received for the affected lot; users received a “Fiber type does not match card type” error message on the GreenLight XPS Laser… Class IIIFDA’s classJul 27, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 27, 2022ClassClass IIIStatusOngoingWhereArkansas, California, Illinois, Maine, Michigan, North Carolina and Texas
- Medical device recall NeuRx Diaphragm Pacing System (NeuRx DPS), Affected Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is… Class IIIFDA’s classJul 27, 2022in FDA’s Enforcement Report19 statesnamed in where it went PublishedJul 27, 2022ClassClass IIIStatusTerminatedWhereAlabama, California, Colorado, Florida, Georgia, Illinois, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas and West Virginia
- Medical device recall Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the… Class IIIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall YelloPort Elite Universal Seal There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 27, 2022ClassClass IIStatusCompletedWhereNationwide, and Florida, Indiana, Massachusetts and Washington named
- Medical device recall Triton Canister System (finished Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RayStation 9B SP1 An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and Tennessee named
- Medical device recall X80 RADiant Photoelectric Therapy System There is a potential compatibility issue with the systems and replacement treatment applicators. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 27, 2022ClassClass IIStatusOngoingWhereCalifornia, Florida and Kentucky
- Medical device recall RIGHT CORONAL BENDER, TEK1940 Customized coronal rod benders may deform the implant when used with the spinal system devices. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportColoradothe one state its words name PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereColorado
- Medical device recall LEFT CORONAL BENDER, TEK1939 Customized coronal rod benders may deform the implant when used with the spinal system devices. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportColoradothe one state its words name PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereColorado
- Medical device recall Nonsterile convenience kits Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportMissourithe one state its words name PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Nonsterile convenience kit: regard Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportMissourithe one state its words name PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010 Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNebraskathe one state its words name PublishedJul 27, 2022ClassClass IIStatusCompletedWhereNebraska
- Medical device recall MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441 Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Michigan and Ohio
- Medical device recall Hill-Rom PRO+ 36” MRS Surface With X-Ray mattress The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Georgia, Iowa, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Rhode Island, South Dakota, Tennessee, Texas, Vermont and Wisconsin named
- Medical device recall Hill-Rom PRO+ 36” MRS Surface mattress The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Georgia, Iowa, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Rhode Island, South Dakota, Tennessee, Texas, Vermont and Wisconsin named
- Medical device recall Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Georgia, Iowa, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Rhode Island, South Dakota, Tennessee, Texas, Vermont and Wisconsin named
- Medical device recall Hill-Rom PRO+ MRS Surface For Versacare mattress The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Georgia, Iowa, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Rhode Island, South Dakota, Tennessee, Texas, Vermont and Wisconsin named
- Medical device recall Hill-Rom Centrella Pro+ 36” Surface With X-Ray mattress The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Georgia, Iowa, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Rhode Island, South Dakota, Tennessee, Texas, Vermont and Wisconsin named
- Medical device recall Hill-Rom Centrella Pro+ 36” Surface mattress The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Georgia, Iowa, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Rhode Island, South Dakota, Tennessee, Texas, Vermont and Wisconsin named
- Medical device recall Hill-Rom Centrella Pro+ 40” Surface mattress The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Georgia, Iowa, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Rhode Island, South Dakota, Tennessee, Texas, Vermont and Wisconsin named
- Medical device recall (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. The product was mispackaged (swapped). Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, Kansas, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Oregon, South Carolina, Tennessee, Virginia, Washington and Wisconsin named
- Medical device recall ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in… Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ambu VivaSight 2 DLT Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LifeGlobal Fast Freeze Thawing Kit There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement Report31 statesnamed in where it went PublishedJul 27, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Vermont, Washington and Wisconsin
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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