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
Sep 4, 2024 Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure conven... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDU... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, ... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDO... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure conven... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD ... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) PLASTIC P... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 3, 2024 (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with ... Product has been identified as having holes in the packaging. Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 30, 2024 MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 It has been determined that certain Blood Pressure Monitors containing a faulty microchip have fa... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 30, 2024 MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. It has been determined that certain Blood Pressure Monitors containing a faulty microchip have fa... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 30, 2024 MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT. It has been determined that certain Blood Pressure Monitors containing a faulty microchip have fa... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 29, 2024 GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalo... GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (... Class II GE Healthcare
Aug 28, 2024 MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840 Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE HEART CABG CDS, REF CDS983376R Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ... CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable En... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE OPEN HEART PACK, REF DYNJ66216C Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE OPEN HEART, REF DYNJ904261B Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE KIT CV I II, REF DYNJ906071B Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 20, 2024 Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use i... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a ... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a phar... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 5, 2024 GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging proces... GE HealthCare has become aware of an issue where image storage is not possible when Centricity PA... Class II GE Healthcare
Jul 24, 2024 (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 4... The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... Class II Cardinal Health 200, LLC
Jul 24, 2024 (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve,... The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... Class II Cardinal Health 200, LLC
Jul 23, 2024 GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbe... Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not sho... Class II GE Healthcare
Jul 17, 2024 Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used wi... The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Ele... Class II Baxter Healthcare Corporation
Jul 17, 2024 Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with eith... The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Ele... Class II Baxter Healthcare Corporation
Jun 28, 2024 Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300 Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Pr... Class II Baxter Healthcare Corporation
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION ... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... 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.