Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 7, 2023 | Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introdu... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | The System is designed as a modular system with components that include an Ov... | GE HealthCare has become aware of the potential that incorrect torque has been applied to certain... | Class II | GE Hangwei Medical Systems, Co. LTD |
| Nov 7, 2023 | Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Cul... | Potentially defective utility trays in the reagent kits. | Class II | Luminex Corporation |
| Nov 7, 2023 | Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introd... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, ... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 6, 2023 | Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A ... | Reports of a pink or green coloration of the image. If the issue is encountered during a procedur... | Class II | Olympus Corporation of the Americas |
| Nov 6, 2023 | Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides he... | It was determined that the Endotracheal Tube Holder included in certain kits is not compatible wi... | Class II | Sarnova HC, Llc |
| Nov 6, 2023 | Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY | The sterility of microcatheter and infusion system devices cannot be guaranteed. | Class II | Merit Medical Systems, Inc. |
| Nov 6, 2023 | AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 1114... | AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the ... | Class II | Physio-Control, Inc. |
| Nov 6, 2023 | Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/... | The sterility of microcatheter and infusion system devices cannot be guaranteed. | Class II | Merit Medical Systems, Inc. |
| Nov 6, 2023 | Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Ite... | It was determined that the Endotracheal Tube Holder included in certain kits is not compatible wi... | Class II | Sarnova HC, Llc |
| Nov 6, 2023 | Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 2... | The sterility of microcatheter and infusion system devices cannot be guaranteed. | Class II | Merit Medical Systems, Inc. |
| Nov 6, 2023 | CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxid... | Certain factory settings for the device were incorrectly described in the IFU-related to the warn... | Class II | Maquet Medical Systems USA |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; us... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | STERILE PVP, REF DYNDA1649 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE STERILE PREP STICK, REF DYNDA1134 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE BETADINE, REF DYNDA1998 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation | The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 ... | Class II | Liberty Medical Solutions, LLC |
| Nov 3, 2023 | Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automat... | Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delay... | Class II | Inpeco S.A. |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used ... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor | It may create the potential for amplified noise and/or overall signal reduction of the ICM, which... | Class II | Medtronic Inc. |
| Nov 3, 2023 | STERILE PVP SLN KIT, REF DYNDM1097 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion ... | Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Nov 3, 2023 | Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura X... | Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Nov 3, 2023 | Remington MEDICAL Drainage Bag, REF 600-D; | There is an error with the "Use by Date" and "Date of Manufacturer" on the box label. | Class II | Remington Medical, Inc. |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; use... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | PVP SOLUTION SING STRL, REF DYNDA1858 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used ... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used ... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | STERILE PVP SOLUTION, REF DYNDA1907 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE POVIDONE, REF DYNDA2061 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; use... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 2, 2023 | Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02 | One product complaint was received reporting that there was an incorrect adapter in the packaging... | Class II | Biomet, Inc. |
| Nov 2, 2023 | Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 | One product complaint was received reporting that there was an incorrect adapter in the packaging... | Class II | Biomet, Inc. |
| Nov 2, 2023 | Sperm separation media are used to separate motile sperm from other constitue... | The lower layer component of a sperm separation Kit does not match the certificate of analysis. T... | Class II | Fujifilm Irvine Scientific, Inc. |
| Nov 1, 2023 | 24 BLOOD CULTURE KIT, REF DYNDH1632 | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | LITe Decompression Snake Arm, REF 48080230 | Product arm was manufactured with the incorrect clamp component. As a result, the affected produc... | Class II | Stryker Spine |
| Nov 1, 2023 | CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562 | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245 | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561 | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | BLOOD CULTURE KIT, REF DYNDH1647B | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo... | A software issue where "low" and "terminal" battery alerts did not display on the screen to the u... | Class II | Turncare, Inc |
| Nov 1, 2023 | Atrium Oasis Drain Single W / AC, Part No. 3600-100 | A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expira... | Class II | Atrium Medical Corporation |
| Nov 1, 2023 | Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a c... | Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Oct 31, 2023 | PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Numb... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OU... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, 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.