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 8, 2025 | Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valve... | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-F... | Class II | Baxter Healthcare Corporation |
| Aug 4, 2025 | Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar... | Class I | Baxter Healthcare Corporation |
| Aug 4, 2025 | Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar... | Class I | Baxter Healthcare Corporation |
| Aug 4, 2025 | Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar... | Class I | Baxter Healthcare Corporation |
| Jul 31, 2025 | Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-lumi... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording ... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mappin... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 28, 2025 | PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 | Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or dif... | Class II | VANTIVE US HEALTHCARE LLC |
| Jul 28, 2025 | TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 9555... | Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit lea... | Class II | VANTIVE US HEALTHCARE LLC |
| Jul 28, 2025 | PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, ... | Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air De... | Class II | VANTIVE US HEALTHCARE LLC |
| Jul 25, 2025 | Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT,... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 25, 2025 | Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 23, 2025 | Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: ... | Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product informatio... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 14, 2025 | Spectrum IQ Infusion Pump, Product Code 3570009 | Baxter has identified that certain pumps have potentially been released with the grease applied t... | Class II | Baxter Healthcare Corporation |
| Jul 14, 2025 | Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic ... | Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 14, 2025 | Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS | Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) du... | Class I | Baxter Healthcare Corporation |
| Jul 11, 2025 | Plum Duo Infusion System, List Number: 400020401 | ICU Medical identified two sequences of programming events and alarm interactions that may cause ... | Class I | ICU Medical, Inc. |
| Jul 8, 2025 | The Medline General Surgery Tray is customized to meet requirements of the ho... | Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker In... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 20, 2025 | Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 | Certain Spectrum infusion pumps may have an incorrect version of software. | Class I | Baxter Healthcare Corporation |
| Jun 20, 2025 | Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX | Certain Spectrum infusion pumps may have an incorrect version of software. | Class I | Baxter Healthcare Corporation |
| Jun 16, 2025 | SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE01... | SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due t... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 12, 2025 | Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Prepara... | The firm issued a field safety notice after becoming aware of three lots of products not having q... | Class II | Bridge to Life Ltd |
| Jun 12, 2025 | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 12, 2025 | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 12, 2025 | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 12, 2025 | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 30, 2025 | Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mo... | The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook u... | Class I | Baxter Healthcare Corporation |
| May 30, 2025 | Hillrom LikoScale component, Product Code 3156232, used with the following a... | The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook u... | Class I | Baxter Healthcare Corporation |
| May 23, 2025 | Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... | Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 23, 2025 | Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... | Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 23, 2025 | Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... | Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2025 | Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250 | There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile pr... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 13, 2025 | Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Ken... | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... | Class II | Cardinal Health 200, LLC |
| May 13, 2025 | Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendal... | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... | Class II | Cardinal Health 200, LLC |
| May 13, 2025 | SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves w... | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... | Class II | Cardinal Health 200, LLC |
| May 12, 2025 | Baxter Novum IQ Syringe Pump, product code 40800BAXUS, | Baxter has identified a design issue which may cause the pump to detect the presence of a syringe... | Class II | Baxter Healthcare Corporation |
| May 9, 2025 | 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope ... | The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the... | Class II | Baxter Healthcare Corporation |
| May 8, 2025 | GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S | Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will g... | Class II | Ohio Medical Corporation |
| May 6, 2025 | Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E1004... | There is a potential for improper crimps on the signal wires of the actuators which could result ... | Class II | Baxter Healthcare Corporation |
| May 2, 2025 | Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software... | Firm has identified Drug Library Management defects in the software: 1) DLM software does not all... | Class II | ICU Medical, Inc. |
| May 2, 2025 | Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and... | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| Apr 28, 2025 | Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a ... | There were reports of an increase in reactive negative controls and false positive results. | Class II | Abbott Molecular, Inc. |
| Apr 28, 2025 | Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time r... | There were reports of an increase in reactive negative controls and false positive results. | Class II | Abbott Molecular, Inc. |
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.