Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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 5, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall Medfusion Syringe Pump A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medfusion Syringe Pump A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medfusion Syringe Pump A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medfusion Syringe Pump A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water… Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. Class IIFDA’s classOct 18, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall Procedure packs Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Procedure packs Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Procedure pack: Presource PBDS, Cat Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Procedure packs Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Procedure packs Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Procedure packs Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Procedure packs Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Procedure pack: Presource PBDS Cat Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Procedure packs XXX Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Presource Fistulogram Pack, Cat Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall BD Pyxis CII Safe ES When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Iowa, Kansas, Louisiana, Massachusetts, Michigan, North Carolina, Nevada and New York named
- Medical device recall MED-810A Zemits NDPrime Laser products Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GAMMEX NON-LATEX PI GREEN Surgical gloves Some surgical glove sterile pouches were not completely sealed. Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Illinois, Indiana, New York, Ohio, South Carolina, Tennessee, Virginia and Wisconsin named
- Medical device recall NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves Some surgical glove sterile pouches were not completely sealed. Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Illinois, Indiana, New York, Ohio, South Carolina, Tennessee, Virginia and Wisconsin named
- Medical device recall REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Class IIFDA’s classOct 18, 2023in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereArizona, Florida, Iowa, Indiana, Kentucky, Minnesota, New York, Ohio, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall Constellation Vision System Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereGeorgia, Illinois and Puerto Rico
- Medical device recall Access Thyroglobulin Calibrators It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MAZOR X robotic guidance system Software update Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Hawaii, Indiana, Kansas, Louisiana, Minnesota, New Jersey, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas and Washington named
- Medical device recall EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Hawaii, Indiana, Kansas, Louisiana, Minnesota, New Jersey, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas and Washington named
- Medical device recall Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 Technopath Manufacturing Ltd. Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois named
- Medical device recall Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19 Technopath Manufacturing Ltd. Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois named
- Medical device recall Multichem P, Part Code 08P90-10 Technopath Manufacturing Ltd. Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois named
- Medical device recall DxI 9000 Access Immunoassay Analyzer The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BACTEC Plus Aerobic/F Culture Vials Certain vials of the BD BACTEC” Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than… Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS… This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 11, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 11, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 11, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 11, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 11, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 11, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS… This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 11, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 11, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall Proboscis/Piston Assembly Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana 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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