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 7, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope,… The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope,… The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical… The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Dexcom Receiver It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PediaLift Access Device, Device Identifier: B751PDLFT0 The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the original vendor of the mattress showing that they are in compliance… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereIndiana, New Jersey, New York, Ohio and Pennsylvania
- Medical device recall Reinforced Introducer Sets Maquet 7 Fr. Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report36 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Reinforced Introducer Sets Maquet 7.5 Fr. Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report36 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Reinforced Introducer Sets Maquet 8 Fr. Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report36 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Outlook Safety Infusion System Y-type Blood Set Potential for leakage at the joint between the blood filters and tubing Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Y-Type Blood Set Potential for leakage at the joint between the blood filters and tubing Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Y-Type Blood Set Potential for leakage at the joint between the blood filters and tubing Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Y-Type Blood Set Potential for leakage at the joint between the blood filters and tubing Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Y-Type Blood Set Potential for leakage at the joint between the blood filters and tubing Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Safeline Y-Type Blood Set Potential for leakage at the joint between the blood filters and tubing Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Safeline Y-Type Blood Set Potential for leakage at the joint between the blood filters and tubing Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wire Guide, Guidewire, Global Product Number G14326 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Percutaneous Entry Set, Nephrostomy Catheter, Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Percutaneous Malecot Nephrostomy Set, Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Percutaneous Pigtail Nephrostomy Set , Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Urethral Dilation Balloon Catheter with Open Tip , Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Urethral Dilator Set, Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bander Ureteral Diversion Open-End Stent Set, Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall C-Flex Double Pigtail Ureteral Stent Set, Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kwart Retro-Inject Ureteral Stent Set, Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Universa Firm Ureteral Stent, Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Universa Soft Ureteral Stent, Global Product No The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205 Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report45 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report45 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205 Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report45 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660 Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report45 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260 Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report45 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250 Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report45 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250 Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report45 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Cocoon Convective Warming System Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall Cocoon Convective Warming System Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall Jamshidi Bone Marrow Aspiration Needle Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Coated VICRYL (Polyglactin 910) Suture, 18” Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Genius 2 Tympanic Thermometer (discontinued) The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
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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