Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 21, 2023 | Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide ... | A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish ... | Class II | Keystone Industries |
| Jul 21, 2023 | Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live i... | Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-... | Class II | Ambu Inc. |
| Jul 20, 2023 | For intraventricular indications mainly used for operations within the brain ... | Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a ... | Class II | Aesculap Implant Systems LLC |
| Jul 20, 2023 | Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclav... | Reports were received the elastomer cup material is crumbling. | Class II | Cosmedent, Inc. |
| Jul 20, 2023 | PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the su... | Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthal... | Class II | Reichert, Inc. |
| Jul 20, 2023 | Visera Hysterovideoscope Olympus HYF Type V | IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brus... | Class II | Olympus Corporation of the Americas |
| Jul 20, 2023 | Zenition 70. The device is to be used in health care facilities both inside a... | Philips has become aware of the potential for unintended radiation exposure with Zenition 70 syst... | Class II | Philips Medical Systems Nederland B.V. |
| Jul 19, 2023 | NOxBOXi Nitric Oxide Delivery System | Replacement of the internal Sample Pump due to high failure rates. | Class II | NOXBOX LTD |
| Jul 19, 2023 | MultiDiagnost-Eleva | A foot switch pedal may get stuck in the active position when the user releases the pedal, resul... | Class II | Philips Medical Systems Nederland B.V. |
| Jul 19, 2023 | Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F42... | Weakened connection point on the adjustable suspension arm, potentially causing damage or a break. | Class II | IHB OPERATIONS B.V. |
| Jul 19, 2023 | Azurion | A foot switch pedal may get stuck in the active position when the user releases the pedal, resul... | Class II | Philips Medical Systems Nederland B.V. |
| Jul 19, 2023 | Allura Xper series | A foot switch pedal may get stuck in the active position when the user releases the pedal, resul... | Class II | Philips Medical Systems Nederland B.V. |
| Jul 19, 2023 | Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product us... | As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Lab... | Class II | Randox Laboratories Ltd. |
| Jul 18, 2023 | PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter | Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflectin... | Class II | Smiths Medical ASD Inc. |
| Jul 18, 2023 | Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, S... | The healing abutments contain a dimensional condition that may lead to a gap between the healing ... | Class II | Preat Corp |
| Jul 18, 2023 | Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Ste... | The healing abutments contain a dimensional condition that may lead to a gap between the healing ... | Class II | Preat Corp |
| Jul 18, 2023 | Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: Th... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Pro... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, S... | The healing abutments contain a dimensional condition that may lead to a gap between the healing ... | Class II | Preat Corp |
| Jul 18, 2023 | Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Pro... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 17, 2023 | RayCare software, include version number 5A, 5B, 6A, including service packs-... | An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warn... | Class II | RAYSEARCH LABORATORIES AB |
| Jul 17, 2023 | Aquilex Fluid Control System-Intended to provide fluid distension of the uter... | The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflo... | Class II | WOM World Of Medicine AG |
| Jul 14, 2023 | L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile | Wrong product coloring. The paddle clips should be blank, but they are colored blue. | Class II | Peter Lazic Gmbh |
| Jul 14, 2023 | Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrog... | For administration of intravenous fluids to a patient s vascular system utilizing needle-free com... | Class II | Quest Medical, Inc. |
| Jul 14, 2023 | MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Ins... | Product is labeled with incorrect offset. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 14, 2023 | COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 100... | Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected t... | Class II | Copan Diagnostics Inc |
| Jul 14, 2023 | L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile | Wrong product coloring. The paddle clips should be blank, but they are colored blue. | Class II | Peter Lazic Gmbh |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, ... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RA... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300... | Due to a manufacturing defect of a supplier provided component, there is a potential that the aud... | Class II | ICU Medical Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, ... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and... | May have a battery life lasting less than the full 48 hours, requiring the device to be charged m... | Class II | EMPATICA SRL |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | The Chevalier Valvulotome is a device used to disrupt the valves of veins whi... | Burrs (molding flash) on the cutter may tear the harvested vien | Class II | LeMaitre Vascular, Inc. |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATC... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETE... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETE... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED,... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETE... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NO... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 | If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, R... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use... | Sample misidentification could occur under specific conditions and patient management altered b... | Class II | Instrumentation Laboratory |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM,... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETE... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 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.