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 7, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is… The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereArizona, Florida, Georgia, Louisiana, Michigan, Minnesota, Texas and Washington
- Medical device recall SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613 The pin that holds the spring mechanism is not properly mounted. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNew York and Tennessee
- Medical device recall iTotal Hip Replacement System, Total Hip Replacement System The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall PREMIER Cryptococcal Antigen An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Delaware, Illinois, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Carolina, North Dakota, New Jersey, New York, South Carolina, Texas and Virginia named
- Medical device recall LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm),… The reaming guide and the guide rod can’t be screwed into the intended depth. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Iowa, Indiana, Kansas, Michigan, Minnesota and Tennessee named
- Medical device recall Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry… There is a potential for silicone shedding during cleaning and sterilization. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry… There is a potential for silicone shedding during cleaning and sterilization. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant… If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeRoyal(R) Enteral Safe Feed Tube Enteral Safe Feeding Tubes labeled as 6.5 FR X 24” contained 5 FR X 24” Enteral Safe Feeding Tubes. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereTexas and Utah
- Medical device recall PERMA-HAND Silk Suture Size 5, Black 30” The sutures inside the packaging are not the same size or type as indicated on the label. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement Report15 statesnamed in where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Georgia, Kansas, Louisiana, Missouri, Mississippi, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania and Wisconsin
- Medical device recall U by Kotex¿ Sleek¿, Regular Tampons, 18 Count Potential for tampon to come apart upon removal. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall U by Kotex¿ Sleek¿, Regular Tampons, 34 Count Potential for tampon to come apart upon removal. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack Potential for tampon to come apart upon removal. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall U by Kotex¿ Sleek¿, Regular Tampons, 3 Count Potential for tampon to come apart upon removal. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Porcine Anorganic Bone Mineral 4.0cc There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled. Class IIIFDA’s classJan 23, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 23, 2019ClassClass IIIStatusTerminatedWhereFlorida and Texas
- Medical device recall DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General… After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the… Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Kansas, Massachusetts, South Carolina and Virginia named
- Medical device recall Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging… Possible incorrect software version loaded. Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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 Ingenia Elition S, Ingenia Elition X During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement. Class IIFDA’s classJan 16, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereCalifornia, Minnesota, New Jersey, New York, Ohio, Tennessee and Texas
- Medical device recall PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may… Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may… Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ddRCombi Plus FP A component of the device was recalled by a supplier. Class IIFDA’s classJan 16, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereIllinois and Massachusetts
- Medical device recall Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus… There is a risk of detachment of the Compact Gantry Rolling Floor. Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Louisiana and Michigan named
- Medical device recall Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used… Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. Class IIIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 16, 2019ClassClass IIIStatusOngoingWhereNo state named
- Medical device recall IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used… Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. Class IIIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 16, 2019ClassClass IIIStatusOngoingWhereNo state named
- Medical device recall IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used… Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. Class IIIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 16, 2019ClassClass IIIStatusOngoingWhereNo state named
- Medical device recall Presource Kit Total Joint Pack containing a double-wrapped basin component The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation. Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportFloridathe one state its words name PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Discover VH/Millennium VG Nuclear Medicine Imaging System A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect… Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 16, 2019ClassClass IIStatusCompletedWhereNo state named
- Medical device recall VariCam A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect… Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 16, 2019ClassClass IIStatusCompletedWhereNo state named
- Medical device recall MEVION S250i Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportDistrict of Columbiathe one state its words name PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereDistrict of Columbia
- Medical device recall Elekta Unity In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of… Class IIFDA’s classJan 16, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 16, 2019ClassClass IIStatusCompletedWhereTexas and Wisconsin
- Medical device recall Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray… Improper design or specifications. Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Minnesota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for… One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw… Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended… One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw… Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide -… An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 9, 2019in FDA’s Enforcement Report51 statesnamed in where it went PublishedJan 9, 2019ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall VITROS Anti-HBe Reagent Pack The firm is extending their previous July 2018 recall to include additional product codes. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS HBeAg Reagent The firm is extending their previous July 2018 recall to include additional product codes. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS NT-proBNP Reagent The firm is extending their previous July 2018 recall to include additional product codes. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium… Dental varnish has the possibility of having an unpleasant and off flavor. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, 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, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4. Class IIIFDA’s classJan 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 9, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Florida, Louisiana, Massachusetts and Nebraska named
- Medical device recall SP CAL (LIQ) Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereIndiana, New Jersey, New York, Texas and West Virginia
- Medical device recall Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces… Potential for leakage due to defect in the thermoset check valve component. Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report31 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10… Potential for leakage due to defect in the thermoset check valve component. Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report31 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4”x9” Cav/20… Potential for leakage due to defect in the thermoset check valve component. Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report31 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Alinity i TSH Reagent Kit, List Number 07P4830 Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in… Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereArkansas, Florida, Georgia, Maryland, Oklahoma and Virginia
- Medical device recall Alinity i Free T4 Reagent Kit, List Number 07P7030 Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in… Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereArkansas, Florida, Georgia, Maryland, Oklahoma and Virginia
- Medical device recall Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in… Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereArkansas, Florida, Georgia, Maryland, Oklahoma and Virginia
- Medical device recall Alinity i Estradiol Reagent Kit, List Number 07P5020 Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in… Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereArkansas, Florida, Georgia, Maryland, Oklahoma and Virginia
- Medical device recall Alinity i Progesterone Reagent Kit, List Number 08P3620 Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in… Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereArkansas, Florida, Georgia, Maryland, Oklahoma and Virginia
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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