Browse Device Recalls
98 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 98 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 98 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. |
| 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. |
| 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. |
| Sep 22, 2017 | Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 c... | Product was placed into distribution prior to completion of all required post sterilization relea... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN)... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H78... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) ... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (U... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model ... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catal... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class II | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 7, 2016 | Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the f... | The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Aug 6, 2014 | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Patter... | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... | Class II | Angiodynamics, Inc. |
| Aug 6, 2014 | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Patter... | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... | Class II | Angiodynamics, Inc. |
| Aug 6, 2014 | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Patter... | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... | Class II | Angiodynamics, Inc. |
| Apr 30, 2013 | AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following ... | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kit... | Class II | Angiodynamics, Inc. |
| Apr 30, 2013 | AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioD... | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kit... | Class II | Angiodynamics, Inc. |
| Jun 15, 2012 | AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size:... | AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter ... | Class II | Angiodynamics Worldwide Headquarters |
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.