Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system Nine complaints reported that the rotatable collar on the filter had detached, causing a leak. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereCalifornia, Florida and Montana
- Medical device recall Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for… potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Iowa, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin named
- Medical device recall therascreen EGFR RGQ PCR Kit There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component Firm has identified product has no staining. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereIndiana, Massachusetts, Missouri, Tennessee and Texas
- Medical device recall ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal… Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Michigan, New Mexico, New York, Ohio and Oregon named
- Medical device recall RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in… Under certain conditions, a marble pattern infrequently appears on the monitor. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maine, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall RadiForce RX360 Under certain conditions, a marble pattern infrequently appears on the monitor. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maine, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall FilmArray BCID Panel, RFIT-ASY-0126, 30 There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FilmArray BCID Panel, RFIT-ASY-0127, 6 There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571 In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereIowa, New York, Pennsylvania, Texas and Wisconsin
- Medical device recall HardyCHROM MRSA,REF False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report15 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereArizona, California, Guam, Iowa, Kansas, Missouri, Montana, Oregon, Puerto Rico, Texas, Utah, US Virgin Islands, Washington, Wisconsin and Wyoming
- Medical device recall Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI:… The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report38 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Comprehensive VRS Inserter, shoulder prosthesis The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Indiana, Kansas, Kentucky, Michigan, Ohio and Texas named
- Medical device recall Histoplasma Immunodiffusion (ID) Antigen False positive results due to potential contamination of reagent. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q… Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet 6.5 Cannulated Screw Tap - Bone fixation screw Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage:… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage:… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage:… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 -… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 -… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product… Distributed to the field without having completed design history files or design transfer activities Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Missouri and New York named
- Medical device recall Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital… Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Wisconsin and West Virginia named
- Medical device recall Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital… Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Wisconsin and West Virginia named
- Medical device recall Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital… Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Wisconsin and West Virginia named
- Medical device recall STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000 Small but detectable holes in the sterilization wrap used with the firm’s 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, 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, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000 Small but detectable holes in the sterilization wrap used with the firm’s 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, 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, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Mazor X Surgical System Positioner Type II There is a potential for the surgical system to detach from the operational room table unexpectedly. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report28 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL A manufacturing error resulted in out of specification R3 Acetabular Shells Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL A manufacturing error resulted in out of specification R3 Acetabular Shells Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL A manufacturing error resulted in out of specification R3 Acetabular Shells Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL A manufacturing error resulted in out of specification R3 Acetabular Shells Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL A manufacturing error resulted in out of specification R3 Acetabular Shells Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNo state 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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