Browse Device Recalls
2,910 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,910 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 2,910 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 11, 2025 | Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098 | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Nu... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number D... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ09230... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ6... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ800... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356 | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Numbe... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 6, 2025 | Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, M... | Devices may have higher than expected amounts of bacterial endotoxin. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 5, 2025 | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code... | There is the potential for missing motor mounting screws, which may have occurred during the serv... | Class I | Baxter Healthcare Corporation |
| Feb 5, 2025 | Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX | There is the potential for missing motor mounting screws, which may have occurred during the serv... | Class I | Baxter Healthcare Corporation |
| Jan 9, 2025 | Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER... | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 9, 2025 | Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, M... | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 6, 2025 | Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Ca... | Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omiss... | Class II | Sysmex America, Inc. |
| 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 |
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.