Medical devices, 2021
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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 7, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Vis-U-All High Temperature Tubing 9”x100’ Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 4.5”x11” Heat Seal Pouch 200 pouches per box Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 6”x10” Heat Seal Pouch 200 pouches per box Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 7.5”x13.5” Heat Seal Pouch 200 pouches per box Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 3.5”x9” Self Seal Pouch 200 pouches per box Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 13”x18” Self Seal Pouch 100 pouches per box Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 4”x11” Self Seal Pouch 200 pouches per box Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 5.5”x10” Self Seal Pouch 200 pouches per box Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 5”x15” Self Seal Pouch 200 pouches per box Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 7.5”x13” Self Seal Pouch 200 pouches per box Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 8”x16” Self Seal Pouch 200 pouches per box Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall enGen Laboratory Automation System, enGen Track System A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Massachusetts, Maryland, North Carolina, Ohio, Texas, Virginia and Vermont named
- Medical device recall VITROS Automation Solutions, VAS A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Massachusetts, Maryland, North Carolina, Ohio, Texas, Virginia and Vermont named
- Medical device recall Pinnacle Cups Certain Pinnacle Cup devices may potentially exhibit an oversized “minor diameter”, which could lead the Apex HE to thread through the shell of the cup without… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin… Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking… Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight… Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010 Gauze sponges contained in custom kits may be flaking or fraying. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall Medtronic Ares Antibiotic-Impregnated Catheter There is a potential for a defect on the seal of the outer pouch of catheters. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 6, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam named
- Medical device recall Medtronic Ares Antibiotic-Impregnated Catheter There is a potential for a defect on the seal of the outer pouch of catheters. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 6, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam named
- Medical device recall Medtronic Ares Antibiotic-Impregnated Catheter There is a potential for a defect on the seal of the outer pouch of catheters. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 6, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam named
- Medical device recall REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8’ Tubing There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Kansas, Maryland, Minnesota, Missouri, Ohio, Oklahoma, Pennsylvania, Rhode Island and Texas named
- Medical device recall Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Kansas, Maryland, Minnesota, Missouri, Ohio, Oklahoma, Pennsylvania, Rhode Island and Texas named
- Medical device recall REF 0930 Adult Elongated CO2/O2 Mask, 7’ Tubing w/ Threaded Nut, Sivel GSE, 10’ GSL X .038” ID X .107” OD,… There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Kansas, Maryland, Minnesota, Missouri, Ohio, Oklahoma, Pennsylvania, Rhode Island and Texas named
- Medical device recall REF 0562F, Adult CO2/O2 Mask, 10’X0.50 GSL w/ Swivel Elbow, 2” Pigtail w/Female Luer Connectors, 7’ Oxygen… There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Kansas, Maryland, Minnesota, Missouri, Ohio, Oklahoma, Pennsylvania, Rhode Island and Texas named
- Medical device recall REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver… There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Kansas, Maryland, Minnesota, Missouri, Ohio, Oklahoma, Pennsylvania, Rhode Island and Texas named
- Medical device recall REF 0562, Adult Elongated O2/CO2 Mask, 10’X0.50 GSL w/ Swivel Elbow, 2” Pigtail w/Female Luer Connectors, 7’… There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Kansas, Maryland, Minnesota, Missouri, Ohio, Oklahoma, Pennsylvania, Rhode Island and Texas named
- Medical device recall Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3 May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line… Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3 May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line… Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereKentucky, Maryland and Rhode Island
- Medical device recall Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereKentucky, Maryland and Rhode Island
- Medical device recall Custom Procedure Kit, Cardiac Cath Pack Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereKentucky, Maryland and Rhode Island
- Medical device recall cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and… Class IIFDA’s classJan 6, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Illinois and West Virginia
- Medical device recall Smoothbore breathing system with exhalation port 22 mm Device The device was assembled with the incorrect exhalation port which can cause gas leakage. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several… Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry… Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several… Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer… The expiration date on labeling is incorrect. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570 Trace amounts of metallic debris were found on the stent related to the manufacturing process. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190 Trace amounts of metallic debris were found on the stent related to the manufacturing process. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria… BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria… BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria… BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria… BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria… BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria… BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Phoenix” PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria… BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria… BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 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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