Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, 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.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK OUS1/ GTIN: 20643169704071… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the… One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Delaware, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maryland, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Virginia, Washington and West Virginia named
- Medical device recall Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 26, 2021ClassClass IIStatusCompletedWhereIllinois and Missouri
- Medical device recall Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 26, 2021ClassClass IIStatusCompletedWhereIllinois and Missouri
- Medical device recall Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 26, 2021ClassClass IIStatusCompletedWhereIllinois and Missouri
- Medical device recall BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall RENOVA SPINE BONE FILLER 10G 12CM CENTIM Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall EASYNJECT, Device for cement infusion in the vertebroplasty procedure Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall 11G DIRECT SINGLE - DELIVERY Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15 Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall 10 GAUGE DRILL, CODE INTVM-DRL Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky and Mississippi named
- Medical device recall Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy… The device may contain a manufacturing defect of a missing resistance spot weld (RSW). Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and North Carolina named
- Medical device recall REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F,… Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F,… Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F,… Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier… Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F,… Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
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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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