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 Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Plus Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Plus Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V60 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Respironics V680 Ventilator Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based… The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Maryland named
- Medical device recall Brain Heart Infusion Agar with 6 ug/ml Vancomycin Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Georgia, Indiana, Massachusetts, Michigan, Puerto Rico, Tennessee, Utah and Washington
- Medical device recall SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereAlabama, Idaho, Maryland, New York and Oklahoma
- Medical device recall SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereAlabama, Idaho, Maryland, New York and Oklahoma
- Medical device recall SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereAlabama, Idaho, Maryland, New York and Oklahoma
- Medical device recall BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect… BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement Report18 statesnamed in where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereAlabama, Connecticut, Florida, Illinois, Indiana, Michigan, Missouri, Mississippi, North Carolina, Nebraska, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall BD Regional Block Needles 22G x 1.50in BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement Report18 statesnamed in where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereAlabama, Connecticut, Florida, Illinois, Indiana, Michigan, Missouri, Mississippi, North Carolina, Nebraska, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Medtronic COBALT HF QUAD CRT-D MRI SureScan Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereGeorgia, New Jersey and Pennsylvania
- Medical device recall Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with… Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereGeorgia, New Jersey and Pennsylvania
- Medical device recall Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator… Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereGeorgia, New Jersey and Pennsylvania
- Medical device recall DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left) The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereArizona, Connecticut, Florida, Massachusetts, New York, Ohio and Pennsylvania
- Medical device recall B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate… Recalled products do not have FDA approval for sale in the United States. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, Minnesota, North Carolina, New Jersey, New York, Pennsylvania, South Dakota, Texas and Washington named
- Medical device recall Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length). Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for… FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. Class IIIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedFeb 3, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Maryland, Missouri, Oregon and Pennsylvania named
- Medical device recall EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System Accelerated battery depletion may result in a need for device replacement earlier than expected. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System Accelerated battery depletion may result in a need for device replacement earlier than expected. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall therascreen PIK3CA RGQ PCR Kit Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, Ohio and Texas
- Medical device recall TRx4851A 2.4 GHz IntelliVue Tele TRX The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRx4841A 1.4 GHz IntelliVue Tele TRX The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement Report16 statesnamed in where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Massachusetts, Missouri, Pennsylvania, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Penumbra JET 7 Reperfusion Catheter The catheter may become susceptible to distal tip damage during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJan 27, 2021ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing The catheter may become susceptible to distal tip damage during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJan 27, 2021ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing The catheter may become susceptible to distal tip damage during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJan 27, 2021ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing The catheter may become susceptible to distal tip damage during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJan 27, 2021ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, New York and Texas named
- Medical device recall OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, New York and Texas named
- Medical device recall Laerdal Compact Suction Unit (LCSU 4) Component failures may cause the unit to lose all suction. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neurosign 100, Product Number 9883-01 A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the… Class IIFDA’s classJan 27, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereMinnesota, North Carolina and New York
- Medical device recall ACUITY Universal Cutter Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide, and Oklahoma named
- Medical device recall REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage:… Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJan 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, North Dakota, New Mexico, Nevada, New York, Ohio, Oklahoma, Tennessee and Virginia named
- Medical device recall REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage:… Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJan 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, North Dakota, New Mexico, Nevada, New York, Ohio, Oklahoma, Tennessee and Virginia named
- Medical device recall REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage:… Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJan 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, North Dakota, New Mexico, Nevada, New York, Ohio, Oklahoma, Tennessee and Virginia 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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