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 |
|---|---|---|---|---|
| Sep 20, 2023 | Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 20, 2023 | Monoject 20 mL Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 20, 2023 | Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 14, 2023 | Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiologica... | GE HealthCare has become aware of an issue where images from two different patients may be contai... | Class II | GE Healthcare |
| Sep 14, 2023 | Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Rad... | GE HealthCare has become aware of an issue where images from two different patients may be contai... | Class II | GE Healthcare |
| Sep 14, 2023 | Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW found... | GE HealthCare has become aware of an issue where images from two different patients may be contai... | Class II | GE Healthcare |
| Sep 13, 2023 | Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Pr... | Syringe contains conical tip that is not compatible with certain needleless IV connector(s). | Class II | Cardinal Health 200, LLC |
| Sep 8, 2023 | Centricity Universal Viewer Workflow Manager, Image processing radiological s... | When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir... | Class II | GE Healthcare |
| Sep 8, 2023 | Universal Viewer Workflow Manager, Image processing radiological system | When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir... | Class II | GE Healthcare |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Fr... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Steri... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexne... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile. | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MH... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) ... | XXX | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced S... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 10, 2023 | Welch Allyn Connex Spot Monitor | Product is being recalled due to the improper placement of a copper tape on the back of the liqui... | Class II | Baxter Healthcare Corporation |
| Aug 10, 2023 | Baxter Epiphany Cardio Server E3 ECG Management System Servers with software ... | Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the... | Class II | Baxter Healthcare Corporation |
| Aug 4, 2023 | HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhal... | Product dispositioned for scrap for sterility failure investigation that was inadvertently shippe... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible wit... | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Gen... | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible... | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 S... | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049 | 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the ti... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 20, 2023 | Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclav... | Reports were received the elastomer cup material is crumbling. | Class II | Cosmedent, Inc. |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, ... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RA... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300... | Due to a manufacturing defect of a supplier provided component, there is a potential that the aud... | Class II | ICU Medical Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, ... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATC... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETE... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETE... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED,... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETE... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NO... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, R... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM,... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETE... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED,... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 12, 2023 | NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Do... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 181... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation mon... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
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.