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 |
|---|---|---|---|---|
| Mar 21, 2025 | Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35 | Drill for use in neurosurgical procedures may have a reverse battery orientation, which may incre... | Class II | Phasor Health, LLC |
| Mar 21, 2025 | Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff ... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and... | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. | Class II | GE Medical Systems, LLC |
| Mar 21, 2025 | Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Pr... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radio... | ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 a... | Class II | Radiometer Medical ApS |
| Mar 20, 2025 | GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA fe... | DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a... | Class II | Agilent Technologies, Inc. |
| Mar 20, 2025 | Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION... | Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the b... | Class II | Channel Medsystems, Inc. |
| Mar 20, 2025 | The Alinity m System is designed to automate the steps for nucleic acid testi... | The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or s... | Class II | Abbott Molecular, Inc. |
| 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 20, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software erro... | Class II | Beckman Coulter Inc. |
| Mar 19, 2025 | Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; ... | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens ... | The occurrence of discrepant high pH results in samples introduced with higher injection volumes ... | Class II | Siemens Healthcare Diagnostics Inc |
| Mar 19, 2025 | Medline procedure kits, labeled as: HAND, REF DYNJ902002J | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; ... | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, P... | Medical device software marketed without FDA clearance . | Class II | Spectrum Medical Ltd. |
| Mar 19, 2025 | Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline Sterile Water, USP, 100mL, REF RDI30295 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens M... | The occurrence of discrepant high pH results in samples introduced with higher injection volumes ... | Class II | Siemens Healthcare Diagnostics Inc |
| Mar 19, 2025 | Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological... | Medical device software marketed without FDA clearance . | Class II | Spectrum Medical Ltd. |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item nu... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 | Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be unde... | Class II | Smith & Nephew, Inc. |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 17, 2025 | Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 | Device may have a small breach in the proximal end of the shaft under the strain relief of the de... | Class II | Abbott |
| Mar 17, 2025 | Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-... | Device may have a small breach in the proximal end of the shaft under the strain relief of the de... | Class II | Abbott |
| Mar 17, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | The reason for the recall is incorrect sample barcode identification and processing errors that r... | Class II | Beckman Coulter Inc. |
| Mar 14, 2025 | DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002) | Potential of compromised compatibility resulting in influence on the positioning of the reference... | Class II | Pro-Med Instruments Gmbh |
| Mar 14, 2025 | Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, Sterile... | Update to IFU to provide additional information related to risk with device over-rotation and mu... | Class II | Merit Medical Systems, Inc. |
| Mar 14, 2025 | Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners,... | Update to IFU to provide additional information related to risk with device over-rotation and mu... | Class II | Merit Medical Systems, Inc. |
| Mar 14, 2025 | Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 | A potential weakness has been identified in the probe body, so that, in a specific production bat... | Class II | ESAOTE S.P.A. |
| Mar 13, 2025 | Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage... | The potential for risk of microbiological contamination of products due to inability to ensure st... | Class II | INSTITUT GEORGES LOPEZ |
| Mar 12, 2025 | Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Refe... | Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test r... | Class II | Qiagen Sciences LLC |
| Mar 11, 2025 | BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-... | Users trying to restock a single bin location of an automated dispensing cabinet, during pocket e... | Class II | CareFusion 303, Inc. |
| Mar 11, 2025 | Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN):... | Incorrect software flagging may occur for the assay that may potentially lead to an erroneous res... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 11, 2025 | BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYX... | Due to a software issue, when attempting to restock the automated dispensing cabinet, user have r... | Class II | CareFusion 303, Inc. |
| Mar 11, 2025 | BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD P... | Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancie... | Class II | CareFusion 303, 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.