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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 31, 2018 | Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light ... | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... | Class II | Cardinal Health 200, LLC |
| Oct 31, 2018 | Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light ... | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... | Class II | Cardinal Health 200, LLC |
| Oct 10, 2018 | L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic f... | Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of... | Class II | Baxter Healthcare Corporation |
| Oct 5, 2018 | EVO Excel, Emission Computed Tomographic System, Material Number 10910501 | The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be l... | Class II | Siemens Medical Solutions USA, Inc. |
| Sep 28, 2018 | Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 105... | The terminals on the plug may become loose and overheat. | Class II | Siemens Medical Solutions USA, Inc. |
| Sep 28, 2018 | Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material... | The terminals on the plug may become loose and overheat. | Class II | Siemens Medical Solutions USA, Inc. |
| Sep 17, 2018 | BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with... | The power supply unit for the printer used with the device can potentially overheat or cause a fi... | Class II | Leica Microsystems, Inc. |
| Sep 12, 2018 | EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used t... | Potential ability to leak once used for compounding. | Class II | Baxter Healthcare Corporation |
| Sep 12, 2018 | EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to... | Potential ability to leak once used for compounding. | Class II | Baxter Healthcare Corporation |
| Sep 12, 2018 | EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to... | Potential ability to leak once used for compounding. | Class II | Baxter Healthcare Corporation |
| Sep 12, 2018 | EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to... | Potential ability to leak once used for compounding. | Class II | Baxter Healthcare Corporation |
| 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 |
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.