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 |
|---|---|---|---|---|
| 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 |
| Jul 12, 2023 | Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OT... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNA... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation moni... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; ... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-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) 18121-000; b)18121-K... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation moni... | 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) 03061-1MO; b) 03061-3MO; c) 03061-OTO... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; ... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation ... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation ... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with th... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitor... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b)... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; ... | 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.