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 FABCO ORS DENTAL ROLLS, 1-1/2” STERILE, COTTON 3/8” Diameter x 1-1/2” Sterility with new cotton source not validated Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surpria: Software Version V3.11, V3.22 Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surpria 64: Software Version V3.11, V3.22 Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the… Primary Pump Tubing Spare Part is incorrect. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Massachusetts, Maryland, Pennsylvania, South Dakota and Wisconsin named
- Medical device recall Philips BiPAP A30 Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2022in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 14, 2022ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Philips BiPAP A40 Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2022in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 14, 2022ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Philips BiPAP V30 Auto Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2022in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 14, 2022ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Philips OmniLab Advanced+ Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2022in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 14, 2022ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Philips OmniLab Advanced+ Intl (Flow Gen) Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2022in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 14, 2022ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Philips OmniLab Advanced + with Heated Tube Humidifier Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2022in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 14, 2022ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with… Excessive ultraviolet-C radiation Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS XT 3400 Chemistry System with Version 3.7.2 and below Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED… Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS XT 7600 Integrated System with Version 3.7.2 and below Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED… Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile… Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 14, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Indiana, Massachusetts, Maine, New Hampshire, New Mexico, New York, Ohio, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 14, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Maryland, Missouri, North Carolina, New York and Texas named
- Medical device recall Abbott Alinity m SARS-CoV-2 CTRL Kit Reports received of an increase of message code 9186 (internal control failed) when using the kit. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Optima Coil System Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona and Florida
- Medical device recall Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10 Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port,… Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedSep 14, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port,… Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedSep 14, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Medline CHEST TUBE REORDER NO: DYNJ36762A Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 14, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama named
- Medical device recall Early Bird Bleed Monitoring System Introducer Sheath Set Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to… Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedSep 14, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, Connecticut, Florida, Georgia, Louisiana, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and West Virginia named
- Medical device recall MEGA 8Fr 50cc Intra-Aortic Balloon Catheter Certain lots containing undersized dilator. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter Certain lots containing undersized dilator. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter Certain lots containing undersized dilator. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall VYGON DRESSING CHANGE W/MAXISWAB kit Potential for incomplete seals. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedSep 14, 2022ClassClass IIStatusOngoingWherePennsylvania
- Medical device recall Various Angiography packs/trays Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various Angiography/Cath Lab packs/trays Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various Pacemaker Packs, Cardio Thoracic Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various PICC Line, Central Line Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various ENT Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various Laparoscopy Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various Cysto Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various Port Insertion Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Breast Abdominoplasty Pack Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various convenience packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various convenience packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various neurology packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various ob/gyn packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various hysterectomy, vaginal packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various C-section packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall D&C pack Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall Various eye packs, cataract packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2022ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota and Texas
- Medical device recall NIM CONTACT EMG Endotracheal Tube The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall NIM EMG Endotracheal Tube The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall NIM EMG Endotracheal Tube The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost C50 1.1 Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect… Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental… Potential for the incorrect screw to be included in the package. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereGeorgia and Texas
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.