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 |
|---|---|---|---|---|
| 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 |
| Mar 3, 2021 | p-Chip Wand Reader | The laser operation might fall under a higher laser class. | Class II | p-Chip Corporation |
| Feb 25, 2021 | In-View Clear Leggings Bulk Non-Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 25, 2021 | Femoral Angiography Drape Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 25, 2021 | Femoral Angiography Drape Bulk Non-Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 25, 2021 | In-View Clear Leggings Sterile Non-Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 25, 2021 | Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the col... | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during ... | Class II | Fenwal Inc |
| Feb 25, 2021 | Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in... | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during ... | Class II | Fenwal Inc |
| Feb 25, 2021 | Amicus Exchange Kit - Product Usage: intended for use in the collection of bl... | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during ... | Class II | Fenwal Inc |
| Feb 25, 2021 | In-View Clear Leggings Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 18, 2021 | SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70... | The product may be contaminated with Burkholderia cepacia | Class II | Sunstar Americas, Inc. |
| Feb 11, 2021 | Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and acces... | The tube holder can separate from the barrier that secures the device to the patients' body. The... | Class II | Hollister Incorporated |
| Feb 11, 2021 | JUDKINS PACK | Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) ... | Class II | Cardinal Health 200, LLC |
| Jan 28, 2021 | Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replaceme... | Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repos... | Class II | Baxter Healthcare Corporation |
| Jan 28, 2021 | Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G50... | Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repos... | Class II | Baxter Healthcare Corporation |
| Jan 28, 2021 | Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacemen... | Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repos... | Class II | Baxter Healthcare Corporation |
| Jan 28, 2021 | Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacemen... | Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repos... | Class II | Baxter Healthcare Corporation |
| Jan 25, 2021 | RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: mon... | Product was compromised during shipment. | Class II | Medline Industries Inc |
| Jan 19, 2021 | Enteral Infusion Pump | The potential for air appearing in the enteral feed pumping set tubing during set-up. | Class II | Cardinal Health 200, LLC |
| Jan 15, 2021 | S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended... | Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O30300... | Class III | 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.