Browse Device Recalls
182 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 182 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 182 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 30, 2024 | MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutane... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG ... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutane... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutane... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutan... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Dec 18, 2023 | PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H78... | Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak du... | Class II | Angiodynamics, Inc. |
| Mar 2, 2023 | NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgic... | Not programmed in accordance with specification. The programming affects the RFID function and do... | Class II | Angiodynamics, Inc. |
| Sep 20, 2022 | Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone ... | Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the ... | Class II | Angiodynamics, Inc. |
| Aug 10, 2022 | VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55... | OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimens... | Class II | Angiodynamics, Inc. |
| Jul 20, 2021 | Solero Generator PG, Item No. H78712740000, Catalog No. 12740000 | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... | Class II | Angiodynamics, Inc. |
| Jul 20, 2021 | Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... | Class II | Angiodynamics, Inc. |
| Jul 20, 2021 | Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12... | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... | Class II | Angiodynamics, Inc. |
| Jul 20, 2021 | Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... | Class II | Angiodynamics, Inc. |
| Mar 10, 2021 | AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: in... | Potential for open seal on sterile product | Class II | Oscor, Inc. |
| Feb 22, 2021 | Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Produc... | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Feb 22, 2021 | AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer... | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Oct 14, 2020 | Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous ... | 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator co... | Class II | Angiodynamics, Inc. |
| May 4, 2020 | BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: Thes... | Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... | Class II | Angiodynamics, Inc. |
| May 4, 2020 | BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated fo... | Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... | Class II | Angiodynamics, Inc. |
| May 4, 2020 | BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are ... | Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... | Class II | Angiodynamics, Inc. |
| May 4, 2020 | BioFlo Midline Convenience Kits - Product Usage: These introducers are used f... | Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... | Class II | Angiodynamics, Inc. |
| Apr 24, 2020 | AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Ele... | Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes t... | Class II | Angiodynamics, Inc. |
| Nov 19, 2019 | MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre... | May result in readings outside of the expected accuracy range. | Class II | Angiodynamics, Inc. |
| Nov 19, 2019 | MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated ... | May result in readings outside of the expected accuracy range. | Class II | Angiodynamics, Inc. |
| Nov 19, 2019 | MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD s... | May result in readings outside of the expected accuracy range. | Class II | Angiodynamics, Inc. |
| Nov 19, 2019 | OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Us... | May result in readings outside of the expected accuracy range. | Class II | Angiodynamics, Inc. |
| Nov 19, 2019 | OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Numbe... | May result in readings outside of the expected accuracy range. | Class II | Angiodynamics, Inc. |
| Oct 2, 2019 | Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 ... | The devices are not labelled correctly. End users impacted by this issue may experience a proced... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 ... | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040... | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 ... | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022 | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-02... | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jun 27, 2019 | AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .01... | The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID... | Class II | Angiodynamics, Inc. |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero G... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Appl... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generat... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Oct 16, 2018 | BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL ... | specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration d... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Oct 16, 2018 | Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE ... | Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration d... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jul 24, 2018 | BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PL... | BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual ste... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS 5F DL BIOFLO PASV, Catalog Number 60M161567 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG... | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalo... | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS 5F DL XPP, Catalog Number 60M030393 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wir... | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.