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 |
|---|---|---|---|---|
| Jan 3, 2025 | Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenien... | Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 31, 2024 | Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item N... | The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess materia... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 31, 2024 | Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600... | The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess materia... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 23, 2024 | AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800, | Hollister received reports of decreased skin barrier wear time which could can lead to tube migra... | Class II | Hollister Incorporated |
| Dec 23, 2024 | AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700, | Hollister received reports of decreased skin barrier wear time which could can lead to tube migra... | Class II | Hollister Incorporated |
| Dec 23, 2024 | CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Cathete... | Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were ei... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 23, 2024 | AnchorFast, Oral Endotracheal Tube Fastener, REF 9799, | Hollister received reports of decreased skin barrier wear time which could can lead to tube migra... | Class II | Hollister Incorporated |
| Dec 23, 2024 | AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787, | Hollister received reports of decreased skin barrier wear time which could can lead to tube migra... | Class II | Hollister Incorporated |
| Dec 23, 2024 | MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containi... | Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were ei... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 20, 2024 | Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2024 | Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2024 | Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538 | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... | Class II | Baxter Healthcare Corporation |
| Dec 20, 2024 | Baxter Solution Set with Duo-Vent Spike, REF 2R8404 | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... | Class II | Baxter Healthcare Corporation |
| Dec 20, 2024 | Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2024 | Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519 | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... | Class II | Baxter Healthcare Corporation |
| Dec 20, 2024 | Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002 | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Dec 16, 2024 | Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2... | Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the req... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 16, 2024 | Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-... | Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the req... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF ... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEM... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | See DocMan | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | See DocMan | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V;... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-U... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, ... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ6... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, ... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PAC... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION P... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | See DocMan | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, R... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, RE... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 19, 2024 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Pro... | Devices were identified as released after repair without full testing being performed, which incl... | Class II | Baxter Healthcare Corporation |
| Nov 19, 2024 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pr... | Devices were identified as released after repair without full testing being performed, which incl... | Class II | Baxter Healthcare Corporation |
| Nov 18, 2024 | Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Re... | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5... | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; trac... | Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF... | Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF... | Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder n... | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tra... | Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | RUMMELL, Medline Item No. ST006ST | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | 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.