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 8, 2024 | Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedure packs containing Shenli syringes, labeled as follows: 1) D... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS119... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Nu... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHRO... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF ... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475 | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF ... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF S... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF S... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 26, 2024 | Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following ... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN,... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYN... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DY... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF C... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK101... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | 1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929 | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT A... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYN... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | 1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W ... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926 | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DY... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS9840... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF D... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ90500... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500 | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 20, 2024 | Baxter Spectrum IQ Infusion Pump, Product Code 3570009 | One device was improperly performed testing prior to release from a Service Center. | Class II | Baxter Healthcare Corporation |
| Mar 20, 2024 | Alinity m System, Part Number: 08N53-002 | The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and t... | Class II | Abbott Molecular, Inc. |
| Mar 15, 2024 | Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in ... | Product was distributed in the United States without proper regulatory approval. | Class II | Baxter Healthcare Corporation |
| Mar 14, 2024 | Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, con... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, cont... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure,... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, co... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C,... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYN... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 12, 2024 | namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIF... | Products have a lack of sterility assurance. | 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.