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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 11, 2020 | AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | GOWN SURG LG W/TOWEL ST BACK, Item Code 9515 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK XLARGE, Gown. Item Code 9548 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK LARGE, Gown. Item Code 9518 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 7, 2020 | Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malays... | There is potential for the sterile wrap to become loose while in transit and compromise the steri... | Class II | Medline Industries Inc |
| Dec 12, 2019 | ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8... | Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for... | Class II | Baxter Healthcare Corporation |
| Dec 12, 2019 | Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8... | Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for... | Class II | Baxter Healthcare Corporation |
| Dec 2, 2019 | Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The I... | Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. | Class II | Medela Inc |
| Nov 25, 2019 | bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an ele... | The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic hig... | Class II | Vyaire Medical |
| Nov 18, 2019 | BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system... | BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than spe... | Class II | Leica Microsystems, Inc. |
| Nov 15, 2019 | Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L | There is the potential presence of particular matter in the header caps of ten lots the Revaclear... | Class II | Baxter Healthcare Corporation |
| Oct 30, 2019 | Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A | The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end... | Class II | Medline Industries Inc |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Sep 25, 2019 | myCordella Patient Kit without ECG, The Cordella System is a comprehensive at... | The firm have received reports of patients myCordella Hubs fully powering themselves down withou... | Class II | ENDOTRONIX |
| Sep 19, 2019 | TherMax Blood Warmer Unit | TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires... | Class II | Baxter Healthcare Corporation |
| Sep 18, 2019 | EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil p... | Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips. | Class II | Medline Industries Inc |
| Sep 18, 2019 | EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following produ... | Potential ability to leak once used for compounding. | Class II | Baxter Healthcare Corporation |
| Sep 6, 2019 | MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: ... | The recall is being conducted due to a potential defective component on the circuit board causing... | Class II | Medline Industries Inc |
| Aug 13, 2019 | EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100... | Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers. | Class III | Baxter Healthcare Corporation |
| Aug 9, 2019 | Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigati... | Samples in the identified lot were found to have incomplete or open packaging seals. | Class II | Medline Industries Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical 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.