Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall Infinity FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Legion FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Phaco Standalone Tips Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alcon Custom Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular… Product labeling contains incorrect expiration date Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois and New Jersey named
- Medical device recall HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis… Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FreeStyle Libre 2 Readers If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn’t used for the full 14-day wear time, then the reader may… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Michigan, New York, Ohio, Texas, Utah and Virginia named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic… Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation… Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive… Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive… Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive… Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting… Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting… Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting… Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting… Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting… Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting… Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting… Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting… Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting… Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting… Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting… Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting… Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS Immunodiagnostic Products Troponin I ES Reagent Pack Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS Immunodiagnostic Products Troponin I ES Calibrators Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and… Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive… Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional… Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive… Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional… Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive… Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Randox RX Series Urea Enzymatic Kinetic Assay Ref Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in… Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide, and California, District of Columbia, Georgia, Minnesota, Missouri, New Jersey, Ohio, Oklahoma, Puerto Rico and Virginia named
- Medical device recall CD HORIZON Spinal System Solera Awl Tip Tap Incorrect Laser Marking - Solera Awl Tip Tap Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Indiana, South Carolina, Texas and Utah named
- Medical device recall UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the… Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic InterStim Ground Pad Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNo state named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
Your shortlist0 of 4
Add one more to compare.