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.

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DateProductReasonClassFirm
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
Mar 12, 2024 Namic FLUID DELIVERY SET, REF 91300040 Products have a lack of sterility assurance. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 11, 2024 HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to positi... Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction ... Class II Baxter Healthcare Corporation
Mar 5, 2024 Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Numb... Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after th... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 5, 2024 Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b)... Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after th... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 5, 2024 Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended fo... Inconsistencies were identified with service records associated with corrections performed for a ... Class II Baxter Healthcare Corporation
Mar 1, 2024 Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray Trumpet Needle Guide ring can detach when excessive pressure is applied. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 1, 2024 Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TR... Trumpet Needle Guide ring can detach when excessive pressure is applied. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 28, 2024 Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b... A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not... Class II Baxter Healthcare Corporation
Feb 28, 2024 Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b)... A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not... Class II Baxter Healthcare Corporation
Feb 28, 2024 Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608... A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not... Class II Baxter Healthcare Corporation
Feb 28, 2024 Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNB... A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not... Class II Baxter Healthcare Corporation
Feb 26, 2024 Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS40... The firm provided a set of specifications for the device, but some units of the device were manuf... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 26, 2024 Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18... Complaints have been received that the device inflation tube detached and/or tore from the main t... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Pro... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697)... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP,... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6"... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product ... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... 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.