Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Zimmer Dermatome AN The devices may have a misaligned thickness control bar. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Halyard, GENERAL LAPAROSCOPY PACK Potential for incomplete seal on header bag. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereGeorgia, Illinois, Maryland and Nebraska
- Medical device recall Halyard, EP LAB PK Potential for incomplete seal on header bag. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereGeorgia, Illinois, Maryland and Nebraska
- Medical device recall Halyard, MIDTOWN GENERAL ARTERIOGRAM Potential for incomplete seal on header bag. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereGeorgia, Illinois, Maryland and Nebraska
- Medical device recall Halyard, MAJOR PACK Potential for incomplete seal on header bag. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereGeorgia, Illinois, Maryland and Nebraska
- Medical device recall Halyard, HEAD AND NECK TRAY Potential for incomplete seal on header bag. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereGeorgia, Illinois, Maryland and Nebraska
- Medical device recall Cardiosave Hybrid The IFU addendum updates the Vibration and Shock Table to reference the correct standards. Class IIIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue The IFU addendum updates the Vibration and Shock Table to reference the correct standards. Class IIIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall GE HealthCare ViewPoint 6 GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 5008X CAREsystem +CLiC +CDX Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereLouisiana, Massachusetts and Minnesota
- Medical device recall Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report24 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Michigan, Missouri, Mississippi, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Virginia and Washington
- Medical device recall HemosIL SynthAFax Recalled lots were manufactured with double the amount of preservative concentration. Class IIIFDA’s classDec 24, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 24, 2025ClassClass IIIStatusOngoingWhereCalifornia, Colorado, Florida and New York
- Medical device recall MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedDec 24, 2025ClassClass IIStatusOngoingWhereWisconsin
- Medical device recall Intelerad InteleShare software, with ProViewer component Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report45 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP*… Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report14 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and Utah
- Medical device recall 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report14 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and Utah
- Medical device recall Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report27 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report27 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Brand Name: AART Chin Implant Product Name: Chin Implant Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report27 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Brand Name: AART Malar Implant Product Name: Malar Implant Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report27 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report27 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Brand Name: AART Calf Implant Product Name: Calf Implant Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report27 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereColorado, Connecticut, Illinois, Massachusetts, Maine, New Hampshire, New Jersey, New Mexico, Ohio, Rhode Island, South Carolina and Texas
- Medical device recall Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereColorado, Connecticut, Illinois, Massachusetts, Maine, New Hampshire, New Jersey, New Mexico, Ohio, Rhode Island, South Carolina and Texas
- Medical device recall Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereColorado, Connecticut, Illinois, Massachusetts, Maine, New Hampshire, New Jersey, New Mexico, Ohio, Rhode Island, South Carolina and Texas
- Medical device recall Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereColorado, Connecticut, Illinois, Massachusetts, Maine, New Hampshire, New Jersey, New Mexico, Ohio, Rhode Island, South Carolina and Texas
- Medical device recall Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereColorado, Connecticut, Illinois, Massachusetts, Maine, New Hampshire, New Jersey, New Mexico, Ohio, Rhode Island, South Carolina and Texas
- Medical device recall Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereColorado, Connecticut, Illinois, Massachusetts, Maine, New Hampshire, New Jersey, New Mexico, Ohio, Rhode Island, South Carolina and Texas
- Medical device recall Myosa for Kids KS1 Due to firm mistakenly distributing product within the U.S. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia and Washington named
- Medical device recall BIOSURE HA SCREW, 6MM x 20 MM Removal of affected lot of screws due to labeling error. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Illinois, Kentucky, Minnesota, North Carolina, Nebraska, New York, Oklahoma, Tennessee, Texas and Utah named
- Medical device recall InPen App, Model/CFN Number: MMT-8061 (Android Users) When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can’t choose to… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report50 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Brand Name: Xpert¿ BCR-ABL Ultra Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report29 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas, Virginia, Washington and Wisconsin
- Medical device recall Brand Name: Xpert¿ BCR-ABL Ultra Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement Report29 statesnamed in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas, Virginia, Washington and Wisconsin
- Medical device recall Alinity ci-series System Control Module (SCM) Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ErgoStar CM 40 Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 17, 2025in FDA’s Enforcement Report10 statesnamed in where it went PublishedDec 17, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Illinois, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Wisconsin
- Medical device recall ErgoStar CM 45 Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 17, 2025in FDA’s Enforcement Report10 statesnamed in where it went PublishedDec 17, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Illinois, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Wisconsin
- Medical device recall ErgoStar CM 55 Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 17, 2025in FDA’s Enforcement Report10 statesnamed in where it went PublishedDec 17, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Illinois, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Wisconsin
- Medical device recall ErgoStar CM 60 Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 17, 2025in FDA’s Enforcement Report10 statesnamed in where it went PublishedDec 17, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Illinois, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Wisconsin
- Medical device recall Azurion R3.0 Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Senographe Pristina, Pristina Serena, and Pristina Serena 3D Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j). Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MEDLINE PERFUSION SYRINGE Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Safe-T-Centesis 6 Fr Catheter Drainage Tray Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously… Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Indiana, Louisiana, Michigan and Minnesota named
- Medical device recall Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and… It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12.… The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereAlabama, Georgia and Texas
- Medical device recall Brand Name: CONSTRUX” Mini PTC Spacer System Product Name: CONSTRUX” Mini PTC Spacer System Labeling contains claims that are not consistently present. Class IIIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 17, 2025ClassClass IIIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: FORZA” PTC Spacer System Product Name: FORZA” PTC Spacer System Labeling contains claims that are not consistently present. Class IIIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 17, 2025ClassClass IIIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: Pillar” SA PTC Spacer System Product Name: Pillar” SA PTC Spacer System Labeling contains claims that are not consistently present. Class IIIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 17, 2025ClassClass IIIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: FIREBIRD” SI Fusion System Product Name: FIREBIRD” SI Fusion System Labeling contains claims that are not consistently present. Class IIIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 17, 2025ClassClass IIIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming 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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