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 Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Voyager Rollator-intended as a mechanical walker Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KWIK-STIK 2 Pack Contamination with S. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereCalifornia, Iowa, Illinois, Louisiana, Massachusetts, Michigan, New York, Pennsylvania, South Dakota, Tennessee, Virginia, Wisconsin and West Virginia
- Medical device recall Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089 Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack… Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois and Ohio named
- Medical device recall Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack… Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois and Ohio named
- Medical device recall SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord) Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect… Class IIFDA’s classJan 26, 2022in FDA’s Enforcement Report9 statesnamed in where it went PublishedJan 26, 2022ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Illinois, Kentucky, Massachusetts, Ohio, Tennessee and Texas
- Medical device recall Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient’s scalp. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Florida and Ohio named
- Medical device recall Proteus 235; Version: PTS-8 versions before PTS-8.7.2 Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment… Class IIFDA’s classJan 19, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNew Jersey, Oklahoma, Tennessee and Virginia
- Medical device recall Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually… The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters. Class IIIFDA’s classJan 19, 2022in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 19, 2022ClassClass IIIStatusTerminatedWhereIllinois, Indiana, Kentucky, Michigan, Missouri, North Carolina, South Carolina and Tennessee
- Medical device recall Vaporizer Sevoflurane Maquet Filling A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 19, 2022ClassClass IStatusOngoingWhereNationwide, and Missouri and Virginia named
- Medical device recall Regard, T AND A - Rogers, sterilized convenience kits Kits lacks rubber latex warning label. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall RefleXion Medical Radiotherapy System - System Label: “*** refleXion Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS). Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide, and California and Texas named
- Medical device recall Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up… (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established;… Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide, and Washington named
- Medical device recall SOMATOM Confidence -Computed tomography systems Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SOMATOM Definition AS-Computed tomography system Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SOMATOM Edge Plus-Computed tomography system Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SOMATOM Definition Edge -Computed tomography system Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray… Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 19, 2022ClassClass IIStatusOngoingWhereNationwide, and Indiana and Ohio named
- Medical device recall OCT-Camera 211 01 A3 Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 19, 2022ClassClass IIStatusOngoingWhereNationwide, and Indiana and Ohio named
- Medical device recall Software BeamAdjust version 2.2 When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific… Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide, and Colorado named
- Medical device recall Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model… Increase in premature device failures Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 19, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GLOBAL UNITE STD STEM SZ 6 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone… Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GLOBAL UNITE STD STEM SZ 8 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone… Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GLOBAL UNITE REV STEM SZ 8 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone… Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GLOBAL UNITE STD STEM SZ 10 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone… Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GLOBAL UNITE REV STEM SZ 10 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone… Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GLOBAL UNITE STD STEM SZ 12 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone… Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GLOBAL UNITE STD STEM SZ 14 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone… Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GLOBAL UNITE STD STEM SZ 16 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone… Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Custom Perfusion kits, with the following product descriptions and corresponding Product is labeled as non-pyrogenic but endotoxin testing was not performed. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJan 19, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Connecticut, Illinois, Indiana, Kentucky, Massachusetts, Maine, Mississippi, New York, Ohio, Rhode Island, Tennessee, Texas and Virginia named
- Medical device recall Flat Panel Detector Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 19, 2022ClassClass IIStatusOngoingWhereNationwide, and Delaware, Florida, Louisiana, Montana, New Jersey, Ohio and West Virginia named
- Medical device recall LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 Customers reported that the device jaws were difficult to open or would not open following application on tissue. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Electri-Cool II Portable Cold Therapy Unit This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to… Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to… Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to… Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod… Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may… Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Massachusetts, Maryland, North Carolina, Tennessee and Texas named
- Medical device recall Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer… (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test… Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement Report16 statesnamed in where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereArizona, California, Florida, Hawaii, Indiana, Kentucky, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas and Virginia
- Medical device recall DYNANAIL MINI, Endcap +6mm The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications,… Class IIFDA’s classJan 12, 2022in FDA’s Enforcement Report9 statesnamed in where it went PublishedJan 12, 2022ClassClass IIStatusOngoingWhereCalifornia, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Texas and Washington
- Medical device recall iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR… The dosage information on the pouch is incorrect; the primary carton label is correct. Class IIIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 12, 2022ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Missouri, New York, Ohio and Tennessee named
- Medical device recall QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075) The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement Report9 statesnamed in where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereAlabama, District of Columbia, Kentucky, Maryland, Maine, New Jersey, Oklahoma, Pennsylvania and Texas
- Medical device recall DBB-06 Hemodialysis Delivery System Device lacks premarket approval. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJan 12, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Missouri, New York, Tennessee and Washington named
- Medical device recall Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement Report41 statesnamed in where it went PublishedJan 12, 2022ClassClass IIStatusOngoingWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar) The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Kansas, Maryland, Texas and Wisconsin named
- Medical device recall Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation… Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3… Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 12, 2022ClassClass IIStatusOngoingWhereNationwide, and Georgia, Michigan, North Carolina and Texas named
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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