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 Beta-Hydroxybutyrate LiquiColor Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. Class IIIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 11, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled) Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. Class IIIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 11, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Synchron CX/DX/LX Beta-Hydroxybutyrate Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. Class IIIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 11, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Cardinal Health Beta-Hydroxybutyrate Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. Class IIIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 11, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. Class IIIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 11, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016 The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 4, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe The device may show unexpected locus specific signals in addition to those at 22q. Class IIFDA’s classAug 4, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Missouri, New York, Pennsylvania, Texas and Utah
- Medical device recall Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover. Class IIFDA’s classAug 4, 2021in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 4, 2021ClassClass IIStatusOngoingWhereGeorgia, Massachusetts, Maryland, New York, South Carolina, Texas, Washington and West Virginia
- Medical device recall Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of… Class IIFDA’s classAug 4, 2021in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 4, 2021ClassClass IIStatusOngoingWhereGeorgia, Massachusetts, Maryland, New York, South Carolina, Texas, Washington and West Virginia
- Medical device recall Infusomat Space Volumetric Pump Administration Set There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on… Class IIFDA’s classAug 4, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereCalifornia, Michigan, Oregon and Utah
- Medical device recall RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in… Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point. Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportTennesseethe one state its words name PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall CARESCAPE PDM-Masimo SpO2 Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down. Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 4, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers… There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. Class IIFDA’s classAug 4, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Illinois, Kansas, Michigan, Missouri, North Carolina, Nebraska and Ohio
- Medical device recall OxyMask O2 Adult Potential for oxygen tubing to disconnect from mask or loosen. Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedAug 4, 2021ClassClass IIStatusOngoingWhereIllinois
- Medical device recall ThermoScientific Oxoid Antimicrobial Susceptibility Discs Out of Specification Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker Misaligned placement of an axis mark can cause the patient to experience blurred vision Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker Misaligned placement of an axis mark can cause the patient to experience blurred vision Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker Misaligned placement of an axis mark can cause the patient to experience blurred vision Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker Misaligned placement of an axis mark can cause the patient to experience blurred vision Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker Misaligned placement of an axis mark can cause the patient to experience blurred vision Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker Misaligned placement of an axis mark can cause the patient to experience blurred vision Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker Misaligned placement of an axis mark can cause the patient to experience blurred vision Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker Misaligned placement of an axis mark can cause the patient to experience blurred vision Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker Misaligned placement of an axis mark can cause the patient to experience blurred vision Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker Misaligned placement of an axis mark can cause the patient to experience blurred vision Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker Misaligned placement of an axis mark can cause the patient to experience blurred vision Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker Misaligned placement of an axis mark can cause the patient to experience blurred vision Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall Proteus 235-Proton Therapy System if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without… Class IIFDA’s classAug 4, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 4, 2021ClassClass IIStatusOngoingWhereFlorida, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery,… Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be… Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Iowa, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes… The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes… The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Medtronic Vectris SureScan MRI Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack… Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 4, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide… There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable. Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Utah, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the… There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable. Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Utah, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers:… Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 4, 2021ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers:… Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 4, 2021ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article… Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 4, 2021ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty… Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn. Class IIFDA’s classAug 4, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10 It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJul 28, 2021ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10 It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJul 28, 2021ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Cotton Rounds/Pads under the following brand names: 1 Potential for mold contamination (Aspergillus vadensis) Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Iowa, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall ANCILLARY ADULT 140-DOSE CONVENIENCE KIT Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits. Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE Exposed to freezing temperatures due to refrigerated truck malfunctions Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereTexas
- Medical device recall The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional… Exposed to freezing temperatures due to refrigerated truck malfunctions Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one… Exposed to freezing temperatures due to refrigerated truck malfunctions Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereTexas
- Medical device recall 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going… Exposed to freezing temperatures due to refrigerated truck malfunctions Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one… Exposed to freezing temperatures due to refrigerated truck malfunctions Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereTexas
- Medical device recall NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component… Exposed to freezing temperatures due to refrigerated truck malfunctions Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereTexas
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.”
Your shortlist0 of 4
Add one more to compare.