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 |
|---|---|---|---|---|
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Pa... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | Clean Catch Kit, SKU DYKM1833A; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Lab Kit, SKU DYLAB1018; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 22, 2024 | Allegedly counterfeit batteries manufactured by CSB batteries being used with... | ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infu... | Class I | ICU Medical, Inc. |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ0404... | Tip protector may fall off within the packaging, resulting in compromised sterile barrier system ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 16, 2024 | MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Con... | The connectors may not allow catheters to be inserted as intended if the connector is not in the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2024 | MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A | The connectors may not allow catheters to be inserted as intended if the connector is not in the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2024 | Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607 | Baxter is aware of several recalls by other manufacturers related to the potential risk of expos... | Class I | Baxter Healthcare Corporation |
| Oct 16, 2024 | MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY,... | The connectors may not allow catheters to be inserted as intended if the connector is not in the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2024 | MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE B... | The connectors may not allow catheters to be inserted as intended if the connector is not in the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2024 | MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL... | The connectors may not allow catheters to be inserted as intended if the connector is not in the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2024 | MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJR... | The connectors may not allow catheters to be inserted as intended if the connector is not in the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2024 | MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE,... | The connectors may not allow catheters to be inserted as intended if the connector is not in the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2024 | MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF P... | The connectors may not allow catheters to be inserted as intended if the connector is not in the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 15, 2024 | Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile. | Some of the suture packages within the convenience kits contain the incorrect needle type/size an... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 15, 2024 | (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile;... | Some of the suture packages within the convenience kits contain the incorrect needle type/size an... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 15, 2024 | (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2... | Some of the suture packages within the convenience kits contain the incorrect needle type/size an... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 11, 2024 | Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagn... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiog... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Dia... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS76005... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ01... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2)... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYN... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY ... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ524... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | Refer to RES or lead review memo for complete list of affected reference/cata... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VAS... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.