Browse Device Recalls

251 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 251 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 251 FDA device recalls.

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Date	Product	Reason	Class	Firm
Aug 15, 2025	Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occlu...	Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the...	Class II	Maquet Cardiovascular, LLC
Aug 15, 2025	Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occlu...	Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the...	Class II	Maquet Cardiovascular, LLC
Aug 15, 2025	Heartstring III Proximal Seal System. Intravascular anastomosis occluder.	Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the...	Class II	Maquet Cardiovascular, LLC
Aug 6, 2025	Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. ...	Reports of out-of-box failures discovered during the limited launch phase. Failure modes included...	Class II	Maquet Cardiovascular, LLC
Mar 20, 2025	The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us...	There have been at least 12 complaints from users as of March 3, 2025, reporting that they identi...	Class II	Maquet Cardiovascular, LLC
Mar 10, 2025	Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of ...	Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro ...	Class II	Maquet Cardiovascular, LLC
Dec 9, 2024	Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model ...	Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching fr...	Class I	Maquet Cardiovascular, LLC
Dec 9, 2024	VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-400...	Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching fr...	Class I	Maquet Cardiovascular, LLC
Oct 16, 2024	Acrobat-i Positioner. Model Number C-XP-5000Z	Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste...	Class II	Maquet Cardiovascular, LLC
Oct 16, 2024	Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z	Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste...	Class II	Maquet Cardiovascular, LLC
Oct 16, 2024	Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z	Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste...	Class II	Maquet Cardiovascular, LLC
Sep 20, 2024	VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W...	There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.	Class I	Maquet Cardiovascular, LLC
May 31, 2024	The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us...	There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40...	Class II	Maquet Cardiovascular, LLC
May 31, 2024	The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use...	There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40...	Class II	Maquet Cardiovascular, LLC
May 17, 2024	The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for us...	Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ...	Class II	Maquet Cardiovascular, LLC
May 17, 2024	The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the fo...	Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ...	Class II	Maquet Cardiovascular, LLC
Dec 13, 2023	Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection	Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If th...	Class I	Maquet Cardiovascular, LLC
Dec 13, 2023	Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit	Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If th...	Class I	Maquet Cardiovascular, LLC
Dec 1, 2023	Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.	Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. T...	Class II	Maquet Cardiovascular, LLC
Dec 1, 2023	Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .	Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. T...	Class II	Maquet Cardiovascular, LLC
Oct 31, 2023	Acrobat-i Vacuum Positioner System, Model Number XP-5000Z	The Positioner Arm may not tighten or lock during normal use.	Class II	Maquet Cardiovascular, LLC
Sep 19, 2023	Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 pri...	Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different...	Class II	Maquet Cardiovascular, LLC
Sep 13, 2023	Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance...	Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epi...	Class II	Maquet Cardiovascular, LLC
Jun 28, 2023	ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a ches...	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil...	Class II	Maquet Cardiovascular, LLC
Jun 28, 2023	ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a ch...	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil...	Class II	Maquet Cardiovascular, LLC
Jun 28, 2023	ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) P...	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil...	Class II	Maquet Cardiovascular, LLC
Jun 28, 2023	ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a c...	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil...	Class II	Maquet Cardiovascular, LLC
Mar 6, 2023	VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500	Some batches of product were not sterilized to their minimum sterilization specification.	Class II	Maquet Cardiovascular, LLC
Mar 6, 2023	VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH...	Some batches of product were not sterilized to their minimum sterilization specification.	Class II	Maquet Cardiovascular, LLC
Mar 6, 2023	VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000	Some batches of product were not sterilized to their minimum sterilization specification.	Class II	Maquet Cardiovascular, LLC
Jan 30, 2023	Fusion Bioline Vascular Graft, Part number M00201503046B0	One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness test...	Class II	Maquet Cardiovascular, LLC
Dec 22, 2022	Hemopro 2 with Vasoshield, Model VH-4001	Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to t...	Class II	Maquet Cardiovascular, LLC
Dec 22, 2022	Vasoshield Syringe Packs, Model VH-5001	Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to t...	Class II	Maquet Cardiovascular, LLC
Apr 29, 2022	INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovin...	Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm,...	Class II	Maquet Cardiovascular, LLC
Feb 9, 2022	Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF ...	Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms ma...	Class II	Maquet Cardiovascular, LLC
Jan 14, 2022	HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 6...	Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 ...	Class II	Maquet Cardiovascular, LLC
Dec 1, 2021	Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890	There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemora...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Produ...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Prod...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemora...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Cod...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC
Apr 7, 2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Cod...	Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a...	Class II	Maquet Cardiovascular, LLC

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.