Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, 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.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Probe Cover, PU and Elastic Blue Bands - 6” x 48”, with hole Item ID: SH17 No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Probe Cover - 6” x 3” x 96”-Ultrasonic Transducer Cover Item ID: SH22 No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Probe Cover 6”x48”- Ultrasonic Transducer Cover Item ID: SH29 No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Probe Cover, PE, Elastic Bands, 15x244cm-6”x96” -Ultrasonic Transducer Cover Item ID: 1006576 No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Probe Cover, PE, Gel and Elastic bands, 6”x96”-Ultrasonic Transducer Cover Item ID: 1006664 No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse… Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report16 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereArizona, California, Delaware, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Tennessee, Washington and Wisconsin
- Medical device recall reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse… Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report16 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereArizona, California, Delaware, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Tennessee, Washington and Wisconsin
- Medical device recall Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing… If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient’s record when viewed in an Electronic… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FREESTYLE LANCETS 28G 100CT Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall AEROCHAMBER PLS W/MASK LRG BLU Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall BD UF PEN 32GX4MM 100 NANO Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall DEXCOM G6 SENSOR 3 PACK Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall VAPORIZER VICKS 1.5GAL Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall ONETOUCH ULTRASOFT LANCETS 100 COUNT Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall ONETOUCH ULTRA TEST STRIPS 25 COUNT Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall ONETOUCH DELICA LANCETS 30G 100 COUNT Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall ONETOUCH DELICA LANCETS 33G 100 COUNT Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall ACCU-CHEK SMARTVIEW 100 TEST STRIPS Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and South Carolina named
- Medical device recall inLight Medical LED Pads used with Polychromatic light technology system LED pads with cord connectors that have v-shaped notches may not have been assembled properly. Class IIIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 30, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Arkansas, American Samoa, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall FilmArray Pneumonia Panel (Penumo) Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process. Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereNationwide, and Minnesota and Oklahoma named
- Medical device recall Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, New York, Ohio, Oregon, Texas, Virginia and Washington named
- Medical device recall Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, New York, Ohio, Oregon, Texas, Virginia and Washington named
- Medical device recall novaplus, General Purpose Kit There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, New York, Ohio, Oregon, Texas, Virginia and Washington named
- Medical device recall Medical Action INDUSTRIES INC., General Purpose Instrument Tray There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, New York, Ohio, Oregon, Texas, Virginia and Washington named
- Medical device recall Medical Action INDUSTRIES INC., Minor Procedure Tray There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, New York, Ohio, Oregon, Texas, Virginia and Washington named
- Medical device recall Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of… Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, Indiana, Maine, Nebraska, Ohio and South Dakota named
- Medical device recall LEGION Posterior Stabilized OXINIUM Femoral Component The device components experienced a manufacturing process error that resulted in surface damage from product handling. Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Nebraska, New York and Texas named
- Medical device recall Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel… Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona named
- Medical device recall Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1… Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona named
- Medical device recall Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Missouri, New Jersey, Pennsylvania, Texas and Washington named
- Medical device recall v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kansas, Michigan, Missouri and Texas named
- Medical device recall v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris” System Display Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kansas, Michigan, Missouri and Texas named
- Medical device recall WorkMate Claris v.1.2 Upgrade Kits Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kansas, Michigan, Missouri and Texas named
- Medical device recall Radiometer ABL90 FLEX Analyzer with E3800 PC units Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall E3800 PC Units (spare parts) Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a… The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Iowa, Illinois, Minnesota, North Dakota, New York, Ohio, South Dakota and Wisconsin named
- Medical device recall Angiographic Guidewire Component The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 23, 2021in FDA’s Enforcement Report11 statesnamed in where it went PublishedJun 23, 2021ClassClass IStatusTerminatedWhereCalifornia, Kentucky, Louisiana, Michigan, Nebraska, New York, Ohio, Oklahoma, Texas, Washington and Wisconsin
- Medical device recall Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with… Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display… Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase… Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, District of Columbia, Florida, Georgia, Indiana, Missouri, North Carolina, Pennsylvania, South Carolina and Texas named
- Medical device recall GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN… The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image… Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Kentucky, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear Potential that a limited number of individual contact lens packages have an incomplete packaging seal. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide
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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