Browse Device Recalls

35,307 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,307 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 35,307 FDA device recalls, Class II.

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DateProductReasonClassFirm
Jul 6, 2023 APK2 Pressure-Sensing Wheelchair Cushions Defective battery pack in wheelchair cushions can overheat resulting in property damage and one p... Class II Aquila Corporation
Jul 6, 2023 SofTech Pressure-Sensing Wheelchair Cushions Defective battery pack in wheelchair cushions can overheat resulting in property damage and one p... Class II Aquila Corporation
Jul 6, 2023 TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fidu... Class II Johnson & Johnson Surgical Vision, Inc.
Jul 6, 2023 Access Thyroglobulin Calibrators It has been determined through an internal investigation that the alternate Access Thyroglobulin ... Class II Beckman Coulter, Inc.
Jul 6, 2023 TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fidu... Class II Johnson & Johnson Surgical Vision, Inc.
Jul 6, 2023 Medtronic InterStim Ground Pad REF 041826 Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with... Class II Medtronic Neuromodulation
Jul 3, 2023 Total Hip Kit, REF DYNJ903275S; surgical convenience kit The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for p... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for p... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for p... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for pat... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for p... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for p... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for pat... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for p... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for p... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for p... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for p... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for p... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jun 30, 2023 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affin... Transducer, an ultrasound system accessory, consists of two parts that are bonded together that m... Class II Philips Ultrasound, Inc.
Jun 30, 2023 LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC ... Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable cu... Class II Cardiac Assist, Inc
Jun 30, 2023 Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interve... Loss of availability of the wireless foot switch during procedures. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 28, 2023 Alcon Custom Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
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 The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be us... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 28, 2023 Constellation Procedure Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 Infinity FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
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
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-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 Centurion FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone c... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 28, 2023 Legion FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink I... Product labeling contains incorrect expiration date Class II Medtronic Neurosurgery
Jun 28, 2023 stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone ... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 28, 2023 Phaco Standalone Tips Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 27, 2023 Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 hole... Thread form issue of the locking holes in that the locking screws would not properly mate with th... Class II Zimmer, Inc.
Jun 26, 2023 Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software Software issue Class II Digisonics, Inc
Jun 26, 2023 Fargo Ortho-K Lens Manufactured lenses are not covered by existing FDA approval Class II PARAGON VISION SCIENCES, Inc
Jun 26, 2023 ISee Ortho-K Lens Manufactured lenses are not covered by existing FDA approval Class II PARAGON VISION SCIENCES, Inc
Jun 23, 2023 Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape... Certain lots of the products have a Naphthalene odor. Class II Microtek Medical Inc.
Jun 23, 2023 YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provid... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to prov... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to p... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, use... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used ... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecol... Certain lots of the products have a Naphthalene odor. Class II Microtek Medical Inc.
Jun 23, 2023 UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿... There is an improperly performed weld between the cone of the sheath lock and tube of the obturat... Class II Scholly Fiberoptic Gmbh
Jun 23, 2023 SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.

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.