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 5, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic… Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device). Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide, and Michigan and Texas named
- Medical device recall Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517 Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 11, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 11, 2020ClassClass IStatusTerminatedWhereArizona, Iowa, Indiana, Massachusetts and North Dakota
- Medical device recall ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of… There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as… Strain should be VIM-1 positive but is confirmed to be VIM-1 negative. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body replacement… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replacement device… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a vertebral… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement… Incorrectly Labeled ‘general medical device,’ printed on the statutory label of the SYNMESH CAGE SYSTEM instead of ‘specially controlled medical device” Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or… 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Connecticut, Florida and Georgia named
- Medical device recall Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by… Corrosion could cause performance failures in the product. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by… Corrosion could cause performance failures in the product. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare… Corrosion could cause performance failures in the product. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare… Corrosion could cause performance failures in the product. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare… Corrosion could cause performance failures in the product. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4” Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall da Vinci Surgical System, IS 4000 One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Washington named
- Medical device recall Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched… Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched… Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hurricane RX Biliary Balloon Dilatation Catheter RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system… Incorrectly installed base. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Minnesota named
- Medical device recall Instructions For Use document of the GPS Trackers. Appropriateness of the language used in the Tracker reprocessing instruction. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereCalifornia, Colorado, South Carolina and Wisconsin
- Medical device recall Merge LIS A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking)… Class IIFDA’s classNov 4, 2020in FDA’s Enforcement Report15 statesnamed in where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee and Texas
- Medical device recall GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the… Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal) There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient… Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient… Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for… Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for… Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LOM Disposable Surgical Gowns/Medical Gowns, Single-Use Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA’s standards for surgical gowns. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedNov 4, 2020ClassClass IIStatusOngoingWhereNew York
- Medical device recall The Quidel Triage BNP Calibrators Product compromised during shipment. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereCalifornia, New York, Texas and Virginia
- Medical device recall Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution). Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Indiana, Louisiana, Michigan, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Texas and Washington named
- Medical device recall Streamline MIS Navigation System Taps The Streamline Navigation System taps have experienced binding with other devices. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Michigan 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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