Browse Device Recalls
3,306 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,306 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 3,306 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 20, 2018 | Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric ... | A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... | Class II | Cardinal Health 200, LLC |
| Feb 20, 2018 | Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML dev... | A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... | Class II | Cardinal Health 200, LLC |
| Feb 7, 2018 | Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. End... | Device may display a battery missing error. | Class II | Medela Inc |
| Feb 6, 2018 | Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product... | Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with ... | Class II | Baxter Healthcare Corporation |
| Feb 1, 2018 | Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR ... | Packaged with an incorrect overwrap. | Class II | Medline Industries Inc |
| Jan 26, 2018 | Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray di... | Error introduced into PET images acquired and reconstructed with VJ20A software. Array values ar... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 25, 2018 | Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW wit... | Potential that one or more image series may be missing from an exam without a user warning disp... | Class II | GE Healthcare |
| Jan 25, 2018 | Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricit... | Potential that one or more image series may be missing from an exam without a user warning disp... | Class II | GE Healthcare |
| Jan 12, 2018 | BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile... | One of the cases of product might not have been sterilized. | Class II | Medline Industries, Inc. |
| Dec 21, 2017 | MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 8... | Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was... | Class II | Baxter Healthcare Corporation |
| Nov 7, 2017 | Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To det... | The Broad Quantification option of the Symbia product software version VB20A may not allow modifi... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 7, 2017 | Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To de... | The Broad Quantification option of the Symbia product software version VB20A may not allow modifi... | Class II | Siemens Medical Solutions USA, Inc. |
| Oct 30, 2017 | Plum 360 Infusion System, List number 30010. | (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" sta... | Class II | ICU Medical Inc |
| Oct 30, 2017 | ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Nu... | Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggybac... | Class II | ICU Medical Inc |
| Oct 23, 2017 | Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pou... | Possible open seal on top portion of the package. Could cause breach of sterility. | Class II | Medline Industries Inc |
| Oct 10, 2017 | MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8 | Products labeled as sterile were distributed prior to sterilization | Class II | Medline Industries Inc |
| Oct 10, 2017 | MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHE... | Products labeled as sterile were distributed prior to sterilization | Class II | Medline Industries Inc |
| Sep 28, 2017 | Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Lu... | Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expr... | Class II | Cosmedent, Inc. |
| Sep 25, 2017 | PROVEO 8 Ophthalmic Microscope System optical instrument for improving the v... | The observed issues can lead to unexpected interruptions of the optics carrier focus drive moveme... | Class II | Leica Microsystems, Inc. |
| Sep 18, 2017 | Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Inte... | The torque wrench used to tighten system bolts during installation was found to be out of tolerance | Class II | Siemens Medical Solutions USA, Inc. |
| Sep 8, 2017 | Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a dil... | There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) res... | Class II | Sysmex America, Inc. |
| Sep 5, 2017 | Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Patient Positioning System with KRC2 controller using software versions 2.3.1... | Communications between the Patient Positioning System and the accuracy filter can periodically fa... | Class II | Forte Automation Systems Inc |
| Sep 5, 2017 | Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline Prefilled 550 ml Sterile¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex Unit Dose 15 ml Normal Saline ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Aug 10, 2017 | Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic ba... | The locking mechanism on the belt may fail to secure/hold the strap when in locked position poten... | Class II | Medline Industries Inc |
| Aug 10, 2017 | Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic ba... | The locking mechanism on the belt may fail to secure/hold the strap when in locked position poten... | Class II | Medline Industries Inc |
| Aug 1, 2017 | Presource(R) Kits (custom surgical/procedural kits): The standard and custom... | The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ i... | Class II | Cardinal Health 200, LLC |
| Jul 28, 2017 | Convertors Robotic Drape with Attached Leggings; Product is packaged as Singl... | Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings. | Class II | Cardinal Health 200, LLC |
| Jul 27, 2017 | Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are in... | A leak may allow for microbial contamination of the sterile fluid path. | Class II | Baxter Healthcare Corporation |
| Jul 18, 2017 | AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE ... | Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect... | Class II | Vyaire Medical |
| Jul 18, 2017 | Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek pla... | Product did not undergo correct sterilization procedures and may potentially be non-sterile. | Class II | Medline Industries Inc |
| Jul 14, 2017 | Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, R... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 14, 2017 | Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intende... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 14, 2017 | Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is int... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 14, 2017 | Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 14, 2017 | Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody i... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 14, 2017 | Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is in... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 14, 2017 | Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is inte... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond 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.