Browse Device Recalls

3,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,087 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 3,087 FDA device recalls in IL.

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DateProductReasonClassFirm
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single S... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 4, 2018 Leica Microsystems products labeled as the following: Leica M320 Microscope S... Possible failure of screws which hold the gas spring fixation bracket in place. Due to this fail... Class II Leica Microsystems, Inc.
May 30, 2018 FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL ... Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufactu... Class II Baxter Healthcare Corporation
May 29, 2018 Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 ... Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our su... Class II Siemens Medical Solutions USA, Inc.
May 8, 2018 AirLife Resuscitation Device, Pediatric labeled as the following: a. Ped... An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct... Class I Vyaire Medical
May 8, 2018 AirLife Resuscitation Device, Adult labeled as the following: a. Adult, ... An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct... Class I Vyaire Medical
Apr 25, 2018 Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400... Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... Class II Baxter Healthcare Corporation
Apr 25, 2018 Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Ex... Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... Class II Baxter Healthcare Corporation
Apr 25, 2018 Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product... Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... Class II Baxter Healthcare Corporation
Apr 25, 2018 Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exa... Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... Class II Baxter Healthcare Corporation
Apr 24, 2018 MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: ... 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 MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40... 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 5.10 US, Product Code 113081 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 24, 2018 Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Con... Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... Class II Baxter Healthcare Corporation
Apr 24, 2018 MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / ... 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 MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet /... 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.XX US, Product Code 115269 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 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.

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.