Browse Device Recalls
99 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 99 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 99 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 03... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100C... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU ... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 0... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACC... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100C... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65C... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 03... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; A... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 03... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Marker... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| 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. |
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.