Browse Device Recalls

78 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 78 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 78 FDA device recalls.

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DateProductReasonClassFirm
Feb 4, 2025 IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UP... Product is mislabeled with the incorrect fill volume. Class II Angiodynamics, Inc.
Nov 25, 2024 AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-20... Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due ... Class II Angiodynamics, Inc.
Jun 18, 2024 SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis.... Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however t... Class II Angiodynamics, Inc.
Jun 18, 2024 SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis.... Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however t... Class II Angiodynamics, Inc.
May 21, 2024 IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO... A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in a... XXX Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attain... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attai... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attain... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in a... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in ... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use ... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attain... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H78710302... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attain... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Jan 30, 2024 MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutan... 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 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the pe... 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 STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the p... 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 STIFF .018 SS/PD ECHO 2.75" PG-Used for the percuta... 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 NON-ECHO 2.75" PG-Used for the percu... 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 10CM STIFF .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.
Jan 30, 2024 MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percuta... 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 NON-ECHO 2.75" PG- Used for the per... 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 STIFF .018 NI/TU ECHO 2.75" PG-Used for the percuta... 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 STIFF .018 SS/PD ECHO 2.75" PG-Used for the percuta... 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 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.

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.