Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e)… Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Aestiva 7900 Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Aespire 7100 Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Aestiva 7100 Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum… Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and Hawaii, Iowa and New Jersey named
- Medical device recall VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with… VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall A1CNow+ Systems (professional use product), Software Version Revision D A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Utah, Virginia and Washington
- Medical device recall A1CNow SELF CHECK (European), Software Version Revision D A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Utah, Virginia and Washington
- Medical device recall Walgreens At-Home A1C Test Kit, Software Version Revision D A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Utah, Virginia and Washington
- Medical device recall ReliOn FastA1C Test, Software Version Revision D A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Utah, Virginia and Washington
- Medical device recall CVS Health At Home A1C Test Kit, Software Version Revision D A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Utah, Virginia and Washington
- Medical device recall Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4” x 4” Elasto-Gel Wound Dressing may be contaminated with mold. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Illinois, Kansas, New York, Ohio, Tennessee, Texas and Virginia
- Medical device recall Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the… Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the… Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the… Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ascension¿ Silicone PIP-Silicone PIP Sz 1 Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall QuickTox 5 Panel Drug Screen DipCard Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT… Class IIIFDA’s classDec 25, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedDec 25, 2019ClassClass IIIStatusTerminatedWhereArizona, California, Florida, Georgia, Kansas, Louisiana, Michigan, Missouri, Mississippi, North Carolina, Oklahoma, Tennessee and Texas
- Medical device recall Medtronic Affinity, 38um Arterial Filter Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on… A limited number of lenses may be mislabeled with the incorrect diopter power. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Artis zee/ zeego Interventional Fluoroscopic X-Ray System In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating… Class IIFDA’s classDec 25, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereTexas and Washington
- Medical device recall smith&nephew PROFIX Mallet, 750 GRAMS There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4… Class IIFDA’s classDec 25, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, North Carolina and Virginia
- Medical device recall Anesthesia Pediatric Circuit 72” The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end of the circuit. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedDec 25, 2019ClassClass IIStatusOngoingWherePennsylvania
- Medical device recall Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68… The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. Class IIIFDA’s classDec 25, 2019in FDA’s Enforcement Report47 statesnamed in where it went PublishedDec 25, 2019ClassClass IIIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, 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, Washington, Wisconsin and Wyoming
- Medical device recall Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20,… The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. Class IIIFDA’s classDec 25, 2019in FDA’s Enforcement Report47 statesnamed in where it went PublishedDec 25, 2019ClassClass IIIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, 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, Washington, Wisconsin and Wyoming
- Medical device recall Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF,… The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. Class IIIFDA’s classDec 25, 2019in FDA’s Enforcement Report47 statesnamed in where it went PublishedDec 25, 2019ClassClass IIIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, 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, Washington, Wisconsin and Wyoming
- Medical device recall NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel),… The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. Class IIIFDA’s classDec 25, 2019in FDA’s Enforcement Report47 statesnamed in where it went PublishedDec 25, 2019ClassClass IIIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, 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, Washington, Wisconsin and Wyoming
- Medical device recall HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube The tracheal and brochial swivel connectors are incorrectly labeled. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Montana, New York and Oklahoma named
- Medical device recall HydroDot brand: Wave Prep 4 oz Product has the potential to be contaminated with Burkholderia cepacia (B. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Massachusetts, New Mexico, Pennsylvania and Wisconsin named
- Medical device recall HydroDot brand: Wave Prep Single use cups, 8.5 gm Product has the potential to be contaminated with Burkholderia cepacia (B. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Massachusetts, New Mexico, Pennsylvania and Wisconsin named
- Medical device recall DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Adapter Percutaneous Pin Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return… Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rhondium OVC3 One Visit Crown The product was mislabeled with an incorrect expiration date. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 25, 2019ClassClass IIStatusCompletedWhereIllinois, New Mexico, Texas and Wisconsin
- Medical device recall OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT May result in readings outside of the expected accuracy range. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Massachusetts, New Jersey, New York, Ohio and Pennsylvania named
- Medical device recall OARtrac PLUS CLINICAL DETECTOR UNIT May result in readings outside of the expected accuracy range. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Massachusetts, New Jersey, New York, Ohio and Pennsylvania named
- Medical device recall MICRO-PSD Electron May result in readings outside of the expected accuracy range. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Massachusetts, New Jersey, New York, Ohio and Pennsylvania named
- Medical device recall MICRO-PSD HDR May result in readings outside of the expected accuracy range. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Massachusetts, New Jersey, New York, Ohio and Pennsylvania named
- Medical device recall MICRO-PSD EXTERNAL BEAM PHOTON May result in readings outside of the expected accuracy range. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Massachusetts, New Jersey, New York, Ohio and Pennsylvania named
- Medical device recall Alliance Tech Medical, Inc Patients have experienced a bad taste associated with the filters. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement Report24 statesnamed in where it went PublishedDec 25, 2019ClassClass IIStatusCompletedWhereAlabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Puerto Rico, Tennessee, Texas, Washington and Wyoming
- Medical device recall Arrow Berman Angiographic Catheter 50cc Potential leak in the balloon extension line. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow Berman Angiographic Catheter 60cm Potential leak in the balloon extension line. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R… Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator’s Manual. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LIFESTREAM Balloon Expandable Vascular Covered Stent Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and… A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 18, 2019in FDA’s Enforcement Report20 statesnamed in where it went PublishedDec 18, 2019ClassClass IStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Virginia
- Medical device recall CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and… A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 18, 2019in FDA’s Enforcement Report20 statesnamed in where it went PublishedDec 18, 2019ClassClass IStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Virginia
- Medical device recall CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and… A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 18, 2019in FDA’s Enforcement Report20 statesnamed in where it went PublishedDec 18, 2019ClassClass IStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Virginia
- Medical device recall CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and… A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 18, 2019in FDA’s Enforcement Report20 statesnamed in where it went PublishedDec 18, 2019ClassClass IStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Medfusion Syringe Pump There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 18, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 18, 2019ClassClass IStatusTerminatedWhereColorado, Maryland and New York
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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