Browse Device Recalls

3,367 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,367 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 3,367 FDA device recalls in IL.

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DateProductReasonClassFirm
Apr 24, 2018 MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 24, 2018 Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Contr... Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... Class II Baxter Healthcare Corporation
Apr 24, 2018 MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 24, 2018 Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Cont... Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... Class II Baxter Healthcare Corporation
Apr 10, 2018 BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium ... Bard Medical Division is recalling the BARD¿ BrachySource¿ Iodine125 Radioactive Seeds in Mick¿ A... Class II Bard Brachytherapy, Inc.
Mar 28, 2018 Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a)... products may be missing a one-way valve on the fluid patient port. Class II Cardinal Health 200, LLC
Mar 12, 2018 Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product ... Final quality control testing was not completed before the devices were distributed.. Class II Ohio Medical Corporation
Feb 23, 2018 GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 204958... A database handling error could occur during the image acquisition process affecting the complete... Class II GE Healthcare
Feb 21, 2018 Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provi... Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET c... Class II Siemens Medical Solutions USA, Inc.
Feb 20, 2018 Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML d... 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 Diabetes. Kit includes a exerciser volumetric 50... 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, 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

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.