Browse Device Recalls

3,306 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,306 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 3,306 FDA device recalls in IL.

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DateProductReasonClassFirm
Jul 14, 2022 The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Cor... There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. Class II Baxter Healthcare Corporation
Jun 29, 2022 MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351... stability failure Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 24, 2022 Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03. The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... Class II Baxter Healthcare Corporation
Jun 24, 2022 Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02. The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... Class II Baxter Healthcare Corporation
Jun 24, 2022 Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01. The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... Class II Baxter Healthcare Corporation
Jun 24, 2022 Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03. The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... Class II Baxter Healthcare Corporation
Jun 24, 2022 Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04. The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... Class II Baxter Healthcare Corporation
Jun 24, 2022 Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01. The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... Class II Baxter Healthcare Corporation
Jun 24, 2022 Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P79... The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... Class II Baxter Healthcare Corporation
Jun 22, 2022 ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: ... There is a potential risk of medication error when using specific Abacus Order Entry & Calculatio... Class I Baxter Healthcare Corporation
Jun 17, 2022 Verigene CDF Nucleic Acid Test, Part No. 30-002-22 There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP... Class II Luminex Corporation
Jun 17, 2022 VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP... Class II Luminex Corporation
Jun 6, 2022 Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ068909... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE M... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, ... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT ... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRA... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B,... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Numb... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 3, 2022 SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numb... The type of screw printed on the traceability record for the patient label is incorrect, but the ... Class II SAFE ORTHOPAEDICS LLC
May 31, 2022 NaviCare Nurse Call/Voalte Nurse Call An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, C... Class II Baxter Healthcare Corporation
May 17, 2022 #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W... Packaging error. Class II Baxter Healthcare Corporation
May 11, 2022 Medline Pill Splitters; 1 each/box; 144 boxes/carton Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade. Class II MEDLINE INDUSTRIES, LP - Northfield
May 10, 2022 VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS Potential for incomplete seals. Class II Stradis Healthcare
Apr 26, 2022 In-Line ventilator adaptor There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara s... Class I Baxter Healthcare Corporation
Apr 26, 2022 In-Line ventilator adaptor There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara s... Class I Baxter Healthcare Corporation
Apr 22, 2022 Surgical Suture Kit There is uncertainty about the integrity of the methods used to ensure the sterile barrier integr... Class II Stradis Healthcare
Apr 21, 2022 MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022 Effluent Sample Bag Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... Class II Baxter Healthcare Corporation
Apr 21, 2022 MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022 MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022 5 Prong Manifold Set (with Luer Connectors) Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... Class II Baxter Healthcare Corporation
Apr 21, 2022 MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022 Locking Cap for PD Catheter Adapter Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... Class II Baxter Healthcare Corporation
Apr 21, 2022 MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022 APD Drain Manifold Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... Class II Baxter Healthcare Corporation
Apr 21, 2022 15 Liters Drain Bag Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... Class II Baxter Healthcare Corporation
Apr 21, 2022 3,65 m Extension Set with Luer-lock Connector Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... Class II Baxter Healthcare Corporation
Apr 13, 2022 NaviCare Nurse Call System provides a comprehensive communication and info... Firm discovered a firmware memory leak with a supplier-manufactured component. Class II Baxter Healthcare Corporation
Apr 13, 2022 AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe Product labeled incorrectly. Class II Northgate Technologies, Inc.
Apr 13, 2022 Voalte Nurse Call System provides a comprehensive communication and inform... Firm discovered a firmware memory leak with a supplier-manufactured component. Class II Baxter Healthcare Corporation
Apr 1, 2022 Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular p... There is a potential for foreign matter. Class II Baxter Healthcare Corporation
Mar 15, 2022 PrisMax System, Product Code 955626 This correction is due to software anomalies occurring during use. If the operator initiates ther... Class II Baxter Healthcare Corporation
Mar 15, 2022 PrisMax System, Product Code 955724 This correction is due to software anomalies occurring during use. If the operator initiates ther... Class II Baxter Healthcare Corporation
Mar 15, 2022 PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701 This correction is due to software anomalies occurring during use. If the operator initiates ther... Class II Baxter Healthcare Corporation
Mar 15, 2022 Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves Product was distributed without being sterilized. Class II Cardinal Health 200, LLC
Mar 11, 2022 Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems There is a quality issue with the three bolts that hold the CT balancing weights, which could cre... Class II Siemens Medical Solutions USA, Inc.
Mar 9, 2022 Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box The mask cuff may disconnect from the device's breathing tube. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 8, 2022 Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8... Product was improperly store which may cause a delay in results. 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.