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 |
|---|---|---|---|---|
| Apr 5, 2024 | Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS... | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... | Class II | Jiangsu Shenli Medical Production Co., Ltd. |
| Apr 4, 2024 | 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0... | Unreleased software was installed on customer systems resulting in the visual feedback on the scr... | Class II | Stryker Leibinger GmbH & Co. KG |
| Apr 4, 2024 | Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ket... | The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on s... | Class II | Macherey Nagel Gmbh & Co. Kg |
| Apr 4, 2024 | Philips IntelliSpace Cardiovascular software, Model 830089. | Study data is not able to be archived, copied, or exported with the cardiovascular software version. | Class II | Philips Medical Systems Nederland B.V. |
| Apr 3, 2024 | InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile shea... | Potential for distal end of the sheath to break off during a procedure. | Class II | Olympus Corporation of the Americas |
| Apr 3, 2024 | The Distal Access Catheter is a single-lumen, braided shaft, variable stiffne... | Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access... | Class II | Stryker Neurovascular |
| Apr 2, 2024 | Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US | Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured befor... | Class II | Fisher & Paykel Healthcare, Ltd. |
| Apr 2, 2024 | Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S) | A packaging seal gap could impact the sterility of the product. | Class II | Andover Healthcare Inc. |
| Apr 2, 2024 | Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStai... | There is the potential for the front plexiglass door of the automated slide processing system to ... | Class II | Agilent Technologies |
| Apr 1, 2024 | EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 | Devices may contain elevated levels of bacterial endotoxin. | Class II | Cook Medical Incorporated |
| Apr 1, 2024 | LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Applicat... | Laser surgical instruments have no specific evidence of a validated reprocessing method, therefor... | Class II | Karl Storz Endoscopy |
| Apr 1, 2024 | EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 | Devices may contain elevated levels of bacterial endotoxin. | Class II | Cook Medical Incorporated |
| Mar 29, 2024 | LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A ... | Due to unsupported 10 year expiration date. | Class II | CORENTEC CO., LTD |
| Mar 29, 2024 | LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N... | Due to unsupported 10 year expiration date. | Class II | CORENTEC CO., LTD |
| Mar 29, 2024 | The Oncology Essentials Package of the Spectral CT imaging system. | Potential for third party oncology marking laser to be reflected off the gantry cover surface, wh... | Class II | Philips North America Llc |
| Mar 29, 2024 | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, s... | Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), ... | Class II | Stryker Leibinger GmbH & Co. KG |
| Mar 28, 2024 | Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator | inability to reprogram one device | Class II | Medtronic Neuromodulation |
| Mar 28, 2024 | RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiati... | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | HORIBA custom configured fluorescence instrument, modular Fluorolog-QM | HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configur... | Class II | Horiba Instruments Incorporated |
| Mar 28, 2024 | RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment ... | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Plannin... | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 15.0.0.430. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 7.0.0.19. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Pl... | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning Sys... | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy ... | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of ... | Out of specification violation of devices that results in a gap existing within the fixture that ... | Class II | Zimmer, Inc. |
| Mar 28, 2024 | RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF ... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475 | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF ... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF S... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5... | According to 21 CFR 1040.10(f)(4), each laser system classified as a Class IIIb or IV laser prod... | Class II | Newport Corp |
| Mar 27, 2024 | Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF S... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 26, 2024 | Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN,... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following ... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N | Complaints have been received with allegations of Incorrect Needle Curvature. | Class II | SURGICAL SPECIALTIES |
| Mar 26, 2024 | Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 25, 2024 | RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic... | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... | Class II | Ossur H / F |
| Mar 25, 2024 | RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic co... | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... | Class II | Ossur H / F |
| Mar 25, 2024 | RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic... | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... | Class II | Ossur H / F |
| Mar 25, 2024 | RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic co... | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... | Class II | Ossur H / F |
| Mar 23, 2024 | 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/7... | Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not select... | Class II | Philips Ultrasound, Inc. |
| Mar 22, 2024 | Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte c... | Product demonstrates low viscosity. | Class II | Parker Laboratories, Inc. |
| Mar 22, 2024 | Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS... | Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information... | Class II | Philips North America Llc |
| Mar 22, 2024 | 1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.