Browse Device Recalls
812 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 812 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 812 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 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 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 | 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 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 |
| Apr 22, 2025 | Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACC... | Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 22, 2025 | Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SK... | Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 22, 2025 | Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A... | Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 9, 2025 | Centurion Sterile Weitlaner Retractor, Reorder: 67315 | Three is the potential for the retractors to puncture through the sterile packaging. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 9, 2025 | Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395 | Three is the potential for the retractors to puncture through the sterile packaging. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 24, 2025 | Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 7... | A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: HAND, REF DYNJ902002J | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; ... | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline Sterile Water, USP, 100mL, REF RDI30295 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; ... | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 19, 2025 | Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792 | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2025 | MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Sal... | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2025 | MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line... | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2025 | MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey... | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2025 | MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & ... | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS ... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model ... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Mo... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Nu... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Mod... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE P... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Refer to RES | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, M... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Mode... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Refer to RES | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK N... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE,... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PAC... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Mode... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAP... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | 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.