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 |
|---|---|---|---|---|
| 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 3 X10 and Unna Z Unna Boot Bandage... | Class II | Medline Industries Inc |
| Nov 22, 2016 | AbbVie PEG Kit 20 FR | AbbVie is issuing an urgent field correction notification due to an increased number of reports o... | Class II | AbbVie Inc. |
| Nov 21, 2016 | Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 5... | Device could cause a patient overpressure situation without any visual or auditory indication or ... | Class II | Northgate Technologies, Inc. |
| Oct 20, 2016 | NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cass... | Incorrect hCG results | Class II | Ekla Corporation |
| Oct 12, 2016 | GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 1... | Potential presence of particulate matter on the blood side of the dialyzer | Class II | Baxter Healthcare Corp. |
| Oct 11, 2016 | ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for t... | Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHIT... | Class II | Abbott Laboratories |
| Sep 28, 2016 | Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum In... | A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to... | Class II | Baxter Healthcare Corp. |
| Sep 28, 2016 | sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum... | A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to... | Class II | Baxter Healthcare Corp. |
| Sep 28, 2016 | V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA S... | A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Ca... | Class II | Baxter Healthcare Corp. |
| Sep 23, 2016 | V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, vario... | Potential risk associated with corrosion demonstrated on the distraction screw surface. | Class II | Cardinal Health 200, LLC |
| Aug 10, 2016 | Rigid Suction Canister 3000 CC and 2000 CC. | Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure dur... | Class II | Medline Industries Inc |
| Aug 5, 2016 | e.cam and Symbia E gamma camera systems with patient beds To detect or ima... | "We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 28, 2016 | Hospira MedNet Medication Management Suite software, version 6.1, List Number... | Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result... | Class II | Hospira Inc., A Pfizer Company |
| Jul 20, 2016 | BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, ... | Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specif... | Class II | Cardinal Health |
| Jul 1, 2016 | Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain pl... | There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) resu... | Class II | Sysmex America Inc |
| Jul 1, 2016 | DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot ... | BD, formerly CareFusion, has identified a potential risk associated with a weld failure which cou... | Class I | Carefusion 2200 Inc |
| Jun 29, 2016 | Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored... | The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packag... | Class II | Carefusion 2200 Inc |
| Jun 29, 2016 | Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module ... | The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packag... | Class II | Carefusion 2200 Inc |
| Jun 27, 2016 | The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sam... | Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as mi... | Class II | Cardinal Health |
| Jun 24, 2016 | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and prod... | Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUA... | Class II | Baxter Healthcare Corp. |
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.