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.

Clear
DateProductReasonClassFirm
Sep 12, 2018 EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to ... Potential ability to leak once used for compounding. Class II Baxter Healthcare Corporation
Sep 4, 2018 Leica M525 F20 Surgical Microscope System The firm received complaints that the instrument tipped over when the swing arm was fully extended. Class II Leica Microsystems, Inc.
Sep 4, 2018 Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological ... Product was assembled with an isolating fiberglass hose within the oven in the wrong position. Th... Class II Leica Microsystems, Inc.
Aug 30, 2018 Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers... Firm received sporadic reports of discoloration on certain lots of the product, which has been id... Class II MEDLINE INDUSTRIES INC
Aug 14, 2018 Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC... The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact wit... Class II Ohio Medical Corporation
Aug 1, 2018 Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model ... A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a ... Class II ICU Medical Inc
Jul 27, 2018 Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.... The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsel... Class II Sysmex America, Inc.
Jul 12, 2018 power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguy... There were instances where the power cord socket detached from the back of the AMIA cycler when t... Class II Baxter Healthcare Corporation
Jun 25, 2018 Leica M530 OHX Microscope System Supplied with 100 - 120 Vac. Recall is due to a design weakness of the power insert module. Class II Leica Microsystems, Inc.
Jun 20, 2018 The Tri-Flo Subglottic Suction System Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Sub... Class I Vyaire Medical
Jun 15, 2018 Endoscopic Cleaning Brush, single use, sold in kits and labeled as the follow... There is potential risk of brush detachment during cleaning. If brush detachment is not identifi... Class II Medline Industries Inc
Jun 13, 2018 Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Us... These devices have an incorrect specification against safety standard ISO61010-1. Should a single... Class II Leica Microsystems, Inc.
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double 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 with Pulse Wave Cassette, Cassette Trumpet Valve with... 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, No Probe, Double Spike, Ref ASU1221, ... 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, No Probe, Single Spike, Ref ASU1220, ... 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, Double 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, Trumpet Valve, 5mm x 28cm 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 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

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.