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 Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220 Missing bushing on Liko M220 and M230 causing wear and potential for patient falling Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Missing bushing on Liko M220 and M230 causing wear and potential for patient falling Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KWIK-STIK(TM), Quality control kit for culture media Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. Class IIIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 32MM -4 V40 TAPER VIT HEAD There is a potential for the outer Tyvek lid to de-bond from the sealed package. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedFeb 23, 2022ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL There is a potential for the outer Tyvek lid to de-bond from the sealed package. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedFeb 23, 2022ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall Destino Twist 14F (also branded as Guidestar 14F) There is potential for separation between the threaded hub and threaded cap at the proximal end of the device. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 23, 2022ClassClass IIStatusCompletedWherePennsylvania and Tennessee
- Medical device recall Zenition 50, Model #718096 Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement Report26 statesnamed in where it went PublishedFeb 23, 2022ClassClass IIStatusOngoingWhereArizona, California, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Zenition 70, Model #718133 Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement Report26 statesnamed in where it went PublishedFeb 23, 2022ClassClass IIStatusOngoingWhereArizona, California, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Veradius Unity Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement Report26 statesnamed in where it went PublishedFeb 23, 2022ClassClass IIStatusOngoingWhereArizona, California, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Merete PediatrOS RigidTack Incorrect marketing label (25 mm) was applied to product size 20 mm. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedFeb 23, 2022ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall Exeter V40 Cemented Hip There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportMichiganthe one state its words name PublishedFeb 23, 2022ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Exeter V40 Cemented Hip There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportMichiganthe one state its words name PublishedFeb 23, 2022ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps… There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedFeb 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Guam, Northern Mariana Islands, Puerto Rico and US Virgin Islands named
- Medical device recall Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab Kits failed sterility testing and showed evidence of contamination. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereIllinois, Nebraska and Wisconsin
- Medical device recall Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6… Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Illinois, Michigan, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas and West Virginia named
- Medical device recall 1. Arterial Line Kit 20ga x 6” 2. Arterial Line Kit /1 20ga x 6” Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Delaware, Illinois, Indiana, Louisiana, Montana, Nevada, Ohio, Tennessee, Texas and Virginia named
- Medical device recall E25Bio COVID-19 Direct Antigen Rapid Test The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 16, 2022ClassClass IStatusTerminatedWhereNationwide, and Florida, Hawaii and Massachusetts named
- Medical device recall MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL The External Retention Bolster contained in the kit may be a larger diameter than the tube. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL The External Retention Bolster contained in the kit may be a larger diameter than the tube. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Massachusetts, Michigan, North Carolina, New Jersey, New York, Ohio, Tennessee, Texas, Virginia and West Virginia named
- Medical device recall R82 by ETAC Push Brace for High-Low The chrome surface of the push brace can crack during use, potentially cutting the user. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and California and North Carolina named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449 Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone,… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482 Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone,… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483 Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone,… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone,… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone,… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone,… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone,… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone,… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone,… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone,… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone,… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) The incorrect lot number was printed on the foil pouch that the KWIK-STIK” is placed in. Class IIIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM) Potential contamination with S. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and West Virginia named
- Medical device recall LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM) Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and West Virginia named
- Medical device recall QC Sets and Panels: KWIK-STIK” 2 Pack Potential contamination with Escherichia coli Staphylococcus epidermidis and S. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and West Virginia named
- Medical device recall KWIK-STIK, Quality control kit for culture media Tests returning incorrect susceptible results. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms Tests returning incorrect susceptible results. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall QC Sets and Panels, KWIK-STIK AST-GP Tests returning incorrect susceptible results. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall QC Sets and Panels, KWIK-STIK AST-GP Tests returning incorrect susceptible results. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture) Tests returning incorrect susceptible results. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands 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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