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 5, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Philips Laser System Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall Teleflex Medical RUSCH Pocket Pac i.c Product may not be sterile Class IIFDA’s classNov 23, 2022in FDA’s Enforcement Report9 statesnamed in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Missouri, North Carolina, Ohio, Oregon, Tennessee and Texas
- Medical device recall TufTex Embolectomy Catheter Three lots tied by two trainees were released without performing the required pull test. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway) Class IIFDA’s classNov 23, 2022in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereCalifornia, Florida, Michigan, Minnesota, New York, Ohio, Pennsylvania and Texas
- Medical device recall Superion¿ Indirect Decompression System (IDS) Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Wisconsin, West Virginia and Wyoming named
- Medical device recall Hill-Rom Progressa Bed System The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Hawaii, Indiana, Louisiana, Massachusetts, Missouri, North Carolina, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of… Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST)… Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GentleWave System APM Procedure Instrument with Matrix Procedure Instruments with erroneous unit carton labels. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) Procedure Instruments with erroneous unit carton labels. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall Atrium Ocean Wet Suction Water Seal Chest Drain Warehouse experienced temperature excursions in July and August 2021. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Virginia named
- Medical device recall Extension Tabletop for Operating Table System 1140 The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep… Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, New Jersey, South Carolina and Tennessee named
- Medical device recall Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N… Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or… Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of… Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 23, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Illinois, Tennessee and Virginia named
- Medical device recall Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B,… Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3… Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall EasyStand Bantam, with the following sizes Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the… Class IIFDA’s classNov 23, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 23, 2022ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Louisiana, Michigan, Tennessee and Texas
- Medical device recall Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product Due to a defect in the outer pouch sterile seal Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas, Virginia, Washington and West Virginia named
- Medical device recall Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450,… Two customers reported four incidents in which the lifting strap broke while lifting a patient. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 23, 2022ClassClass IIStatusTerminatedWhereNationwide, and California and New York named
- Medical device recall NaturaLyte Liquid Acid concentrate The “Nominal Chemical Composition” section of the label incorrectly lists 5.62g/L KCL (potassium chloride). Class IIFDA’s classNov 16, 2022in FDA’s Enforcement Report21 statesnamed in where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Maryland, Michigan, Missouri, Mississippi, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Texas and Virginia
- Medical device recall Sedecal Soltus Battery Mobile X-Ray System Due to un-commanded movement of mobile x-ray unit. Class IIFDA’s classNov 16, 2022in FDA’s Enforcement Report36 statesnamed in where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034 Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2) Patches… Class IIFDA’s classNov 16, 2022in FDA’s Enforcement Report48 statesnamed in where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall FERNO POWER X1 AMBULANCE COT Batteries could become unstable when not properly maintained and/or subjected to repeated drops, power washing directly into battery contacts or abuse, may… Class IIFDA’s classNov 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 Users are being informed that the product should not be used on infants/neonates. Class IIFDA’s classNov 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204 Users are being informed that the product should not be used on infants/neonates. Class IIFDA’s classNov 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304 Users are being informed that the product should not be used on infants/neonates. Class IIFDA’s classNov 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104 Users are being informed that the product should not be used on infants/neonates. Class IIFDA’s classNov 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A Users are being informed that the product should not be used on infants/neonates. Class IIFDA’s classNov 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A Users are being informed that the product should not be used on infants/neonates. Class IIFDA’s classNov 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600 Users are being informed that the product should not be used on infants/neonates. Class IIFDA’s classNov 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in Users are being informed that the product should not be used on infants/neonates. Class IIFDA’s classNov 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754 Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow… Class IIFDA’s classNov 16, 2022in FDA’s Enforcement Report54 statesnamed in where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752 Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow… Class IIFDA’s classNov 16, 2022in FDA’s Enforcement Report54 statesnamed in where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Y-CONNECTOR: 6” Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock,… Sterile extension sets were distributed without an expiration date Class IIFDA’s classNov 16, 2022in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 16, 2022ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Michigan, New Mexico, Ohio, Oregon, Tennessee, Texas, Utah and Wisconsin
- Medical device recall Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial… Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing. Class IIFDA’s classNov 16, 2022in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedNov 16, 2022ClassClass IIStatusOngoingWhereCalifornia
- Medical device recall Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of… Incorrect configuration of the blades in the package. Class IIFDA’s classNov 16, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 16, 2022ClassClass IIStatusOngoingWhereFlorida, Georgia, Indiana, Louisiana, Massachusetts, Maine and Virginia
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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