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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 21, 2017 | Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Si... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx ... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Si... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only.... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For ... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. ... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx ... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use O... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx ... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only.... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Sin... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use On... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use O... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use O... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For S... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single U... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 21, 2017 | Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Sin... | Product's seal possibly compromised, potentially compromising the sterility of the package conten... | Class II | Cardinal Health 200, LLC |
| Apr 18, 2017 | ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent micr... | Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube t... | Class II | Abbott Laboratories |
| Apr 12, 2017 | LASER CDS | Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep"... | Class II | Medline Industries, Inc. |
| Apr 12, 2017 | Laparoscopy CDS | One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled st... | Class II | Medline Industries, Inc. |
| Apr 12, 2017 | Cardiac Insulation Pad, OPEN HEART CDS | Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation ... | Class II | Medline Industries, Inc. |
| Apr 12, 2017 | PICC Tray, STERILE, 12 packs each per case. | Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit com... | Class II | Medline Industries, Inc. |
| Apr 12, 2017 | Art-Line Surgery Pack-LF, STERILE, 40 packs each per case. | Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit com... | Class II | Medline Industries, Inc. |
| Mar 23, 2017 | Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wa... | Reported customer complaints of automated hematology analyzers catching fire due to misalignment ... | Class II | Sysmex America Inc |
| Mar 20, 2017 | ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology an... | When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it ... | Class II | Roho Inc. |
| Feb 23, 2017 | Manometer, 550 ml three-Way Stopcock; STERILE; | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.)... | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE; | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.... | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | Thoracentesis/ Paracentesis Kit 10/CS; STERILE; | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G ... | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 15, 2017 | Prismaflex Control Unit. Dialyzer, high permeability with or without sealed ... | Firm has received reports of device operators failing to adhere to instructions for use pertainin... | Class II | Baxter Healthcare Corporation |
| Feb 3, 2017 | CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product... | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the ad... | Class II | CORPAK MedSystems, Inc. |
| Feb 3, 2017 | CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); P... | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the ad... | Class II | CORPAK MedSystems, Inc. |
| Feb 3, 2017 | CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended... | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the ad... | Class II | CORPAK MedSystems, Inc. |
| Jan 4, 2017 | Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system i... | Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix D... | Class II | Baxter Healthcare Corporation |
| Jan 4, 2017 | Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system i... | Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix D... | Class II | Baxter Healthcare Corporation |
| Dec 30, 2016 | Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable ... | Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops,... | Class II | Hospira Inc., A Pfizer Company |
| Dec 16, 2016 | APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in... | Customer complaints received for the presence of leaks | Class II | Baxter Healthcare Corporation |
| Dec 14, 2016 | 10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for:... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for:... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medl... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: ... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medl... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recov... | Organ preservation fluid recalled due to potential for bacterial contamination. | Class II | Organ Recovery Systems, Inc. |
| Dec 12, 2016 | Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL ... | Product was not sterilized. Product was shipped to distribution centers instead of the sterilizat... | Class II | MEDLINE IND |
| Nov 23, 2016 | Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in ... | Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3X10 and Unna Z Unna Boot Bandage... | Class II | Medline Industries 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.