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 Electrostatic Filter Angled The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for… Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide, and Delaware, Kentucky, New York, Texas, Virginia, Vermont and Washington named
- Medical device recall Mechanical Filter with Connector Small, Tethered Cap The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for… Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide, and Delaware, Kentucky, New York, Texas, Virginia, Vermont and Washington named
- Medical device recall Adult-Pediatric Electrostatic Filter HME The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for… Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide, and Delaware, Kentucky, New York, Texas, Virginia, Vermont and Washington named
- Medical device recall HME for Tracheostomized Patients The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for… Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide, and Delaware, Kentucky, New York, Texas, Virginia, Vermont and Washington named
- Medical device recall Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000 Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx. Specific lots may have been manufactured with insufficient or incomplete welds. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee and Texas named
- Medical device recall OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming,… Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS… Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall COVID-19 Self-Test Kit *** INNOVA *** 7T Due to distributing test kits to customers who were not part of a clinical investigation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJun 16, 2021ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test… Due to distributing test kits to customers who were not part of a clinical investigation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJun 16, 2021ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall COVID-19 Self-Test Kit *** INNOVA *** 3T Due to distributing test kits to customers who were not part of a clinical investigation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJun 16, 2021ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall ADULT CHEST TUBE TRAY Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 16, 2021ClassClass IStatusTerminatedWhereNationwide, and Arizona, Illinois, Louisiana, Missouri, Mississippi, Tennessee and Texas named
- Medical device recall FISTULA ON-OFF KIT Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 16, 2021ClassClass IStatusTerminatedWhereNationwide, and Arizona, Illinois, Louisiana, Missouri, Mississippi, Tennessee and Texas named
- Medical device recall FISTULA (ON/OFF) ALL IN ONE BAG Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 16, 2021ClassClass IStatusTerminatedWhereNationwide, and Arizona, Illinois, Louisiana, Missouri, Mississippi, Tennessee and Texas named
- Medical device recall DIALYSIS ACCESS Medical convenience kit, Avid Medical Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 16, 2021ClassClass IStatusTerminatedWhereNationwide, and Arizona, Illinois, Louisiana, Missouri, Mississippi, Tennessee and Texas named
- Medical device recall WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut Nonconformities were discovered to the engineering specifications for implant plates and screws. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereIndiana, Pennsylvania and Virginia
- Medical device recall Ingenia Ambition X The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement Report11 statesnamed in where it went PublishedJun 16, 2021ClassClass IIStatusOngoingWhereFlorida, Georgia, Michigan, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Texas and Vermont
- Medical device recall Ingenia Ambition S The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement Report11 statesnamed in where it went PublishedJun 16, 2021ClassClass IIStatusOngoingWhereFlorida, Georgia, Michigan, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Texas and Vermont
- Medical device recall Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression… Product is impacted by a thread profile defect due to a manufacturing issue. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2” Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Atec Insignia Anterior Cervical Plate System There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock… Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Massachusetts, North Carolina, New Mexico, New York, Oklahoma, South Carolina, Texas and Washington named
- Medical device recall Atec Insignia Anterior Cervical Plate System There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock… Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Massachusetts, North Carolina, New Mexico, New York, Oklahoma, South Carolina, Texas and Washington 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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