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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 2, 2021 | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long ... | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Oct 27, 2021 | Neuro Convenience Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | Class II | Medline Industries Inc |
| Oct 27, 2021 | Bedside PICC CDS Convenience Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | Class II | Medline Industries Inc |
| Oct 27, 2021 | Major Vascular CDS Convenience Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | Class II | Medline Industries Inc |
| Oct 27, 2021 | Venous Access Pack-LF Convenience Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | Class II | Medline Industries Inc |
| Oct 27, 2021 | EVLP Convenience Pack/Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | Class II | Medline Industries Inc |
| Oct 25, 2021 | Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M... | The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low s... | Class II | Northgate Technologies, Inc. |
| Oct 22, 2021 | ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 | Product was shipped from a Medline warehouse to a customer at room temperature instead of refrige... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 29, 2021 | Hemodialysis Delivery System, Software Version 2.x. | If the operator initiates therapy with a saved prescription profile and makes a change to the pr... | Class II | Baxter Healthcare Corporation |
| Sep 10, 2021 | Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths) | The belt may fail at lower loads than the labeled 600lbs. | Class II | Kinsman Enterprises Inc |
| Sep 2, 2021 | Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Ali... | There is a potential for false positive results. | Class I | Abbott Molecular, Inc. |
| Sep 2, 2021 | Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Applicat... | There is a potential for false positive results. | Class I | Abbott Molecular, Inc. |
| Sep 2, 2021 | Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alin... | There is a potential for false positive results. | Class I | Abbott Molecular, Inc. |
| Sep 2, 2021 | Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Applic... | There is a potential for false positive results. | Class I | Abbott Molecular, Inc. |
| Sep 2, 2021 | Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Applicat... | There is a potential for false positive results. | Class I | Abbott Molecular, Inc. |
| Aug 18, 2021 | Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultr... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Scrip Inc |
| Aug 18, 2021 | Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultr... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Scrip Inc |
| Aug 6, 2021 | NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF ... | Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potent... | Class II | Medline Industries Inc |
| Aug 6, 2021 | NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H... | Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potent... | Class II | Medline Industries Inc |
| Aug 4, 2021 | Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 Spectru... | Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient sam... | Class II | Abbott Molecular, Inc. |
| Aug 3, 2021 | Verigene EP Amplification Reagent Kit Test | There is potential for false positive results. | Class II | Luminex Corporation |
| Jul 30, 2021 | BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375 | Product may not perform as specified in IFU. | Class II | Leica Microsystems, Inc. |
| Jul 22, 2021 | Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET... | Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirm... | Class II | Baxter Healthcare Corporation |
| Jul 22, 2021 | Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex... | Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed... | Class II | Baxter Healthcare Corporation |
| Jul 7, 2021 | Dose IQ Safety Software used with Spectrum IQ Infusion Pump | Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose ... | Class I | Baxter Healthcare Corporation |
| Jul 1, 2021 | Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, c... | The kits may contain an expired component. | Class II | Medline Industries Inc |
| Jul 1, 2021 | Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired com... | The kits may contain an expired component. | Class II | Medline Industries Inc |
| Jul 1, 2021 | Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing e... | The kits may contain an expired component. | Class II | Medline Industries Inc |
| Jul 1, 2021 | Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expire... | The kits may contain an expired component. | Class II | Medline Industries Inc |
| Jun 30, 2021 | Kaguya Automated Peritoneal Dialysis System | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used wi... | Class II | BAXTER HEALTHCARE CORPORATION |
| Jun 30, 2021 | Sharesource Connectivity Platform for Use with the Amia Automated PD System | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used wi... | Class II | BAXTER HEALTHCARE CORPORATION |
| Jun 15, 2021 | EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites throu... | There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration dat... | Class II | Baxter Healthcare Corporation |
| Jun 4, 2021 | Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 357000... | System errors were noted following changes the customers implemented to the configuration of thei... | Class I | Baxter Healthcare Corporation |
| May 25, 2021 | Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Lar... | Potential for mold contamination (Aspergillus vadensis) | Class II | Medline Industries Inc |
| May 21, 2021 | Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usag... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Pro... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product ... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R ... | Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contam... | Class II | Sunstar Americas, Inc. |
| May 21, 2021 | Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - P... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Numbe... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| May 21, 2021 | Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Ca... | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2021 | Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case,... | The devices may not meet the minimum required sterility assurance level. | Class II | Medline Industries Inc |
| Apr 14, 2021 | Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for... | There is a potential leak between the venous patient connector and patient's hemodialysis access. | Class II | Baxter Healthcare Corporation |
| Mar 23, 2021 | SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA | Product may be contaminated with Burkholderia contaminans. | Class II | Sunstar Americas, Inc. |
| Mar 18, 2021 | VERIGENE Processor SP - Product Usage: intended for processing and identifyin... | Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella sp... | Class II | Luminex Corporation |
| Mar 15, 2021 | Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the... | Possible false negative or false positive results due to the product being compromised during shi... | Class II | Medline Industries Inc |
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.