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 |
|---|---|---|---|---|
| Mar 8, 2022 | ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myogl... | This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a cal... | Class II | Abbott Laboratories |
| Mar 8, 2022 | Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes conta... | The product was stored incorrectly due to improper storage controls which may lead to delayed res... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 4, 2022 | Alinity m HBV Application Specification File (US and CE) | There is a potential for misquantitation high results of negative samples. | Class II | Abbott Molecular, Inc. |
| Mar 4, 2022 | Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride In... | Sterility failure of the exterior of the syringe which may impact the device's ability to be laid... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 4, 2022 | Alinity m HBV AMP Kit (US and CE) | There is a potential for misquantitation high results for negative samples. | Class II | Abbott Molecular, Inc. |
| Feb 25, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H9386... | Product is mislabeled as self-righting Luer slip tip caps, yellow. | Class II | Baxter Healthcare Corporation |
| Feb 25, 2022 | MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C448... | Devices distributed lacked regulatory clearance. | Class II | Baxter Healthcare Corporation |
| Feb 23, 2022 | (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degre... | The finished device package did not contain the IFU. | Class II | Carefusion 2200 Inc |
| Feb 21, 2022 | Liko Universal Twinbar 670 QRH, an accessory that can be used together with m... | An incorrect center bolt was used in the assembly of the product which could result in a patient ... | Class II | Baxter Healthcare Corporation |
| Feb 15, 2022 | VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 | Higher than normal "No Call Internal Control failures" due to a missing reagent within a small su... | Class II | Luminex Corporation |
| Feb 14, 2022 | Compella Bariatric Bed System | Potential damage to the power cord may cause the power conductors to be exposed, thereby creating... | Class II | Baxter Healthcare Corporation |
| Feb 14, 2022 | Compella Therapy Air Supply Unit | Potential damage to the power cord may cause the power conductors to be exposed, thereby creating... | Class II | Baxter Healthcare Corporation |
| Feb 11, 2022 | Alinity m Integrated Reaction Units (IRU) | There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by t... | Class II | Abbott Molecular, Inc. |
| Jan 25, 2022 | meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit... | The product was incorrectly shipped at room temperature rather than refrigerated. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 14, 2022 | BUTLER Clear Dip, 12 bottles/case | Product lacks premarket clearance. | Class II | Sunstar Americas, Inc. |
| Jan 10, 2022 | RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component... | The product does not have 510(k) clearance. | Class I | BASE 10 GENETICS INC |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482 | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482 | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code N... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code N... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, R... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pi... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449 | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, ... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Dec 29, 2021 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pro... | There is the potential for reduced or non-delivery of medication, in some cases without alerting ... | Class I | Baxter Healthcare Corporation |
| Dec 29, 2021 | Baxter Spectrum IQ Infusion Pumps, Product code 3570009. | There is the potential for reduced or non-delivery of medication, in some cases without alerting ... | Class I | Baxter Healthcare Corporation |
| Dec 29, 2021 | MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes | Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 20, 2021 | bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventila... | Potential cessation in ventilation can occur under specific conditions. | Class I | Vyaire Medical |
| Dec 15, 2021 | CURAD REUSABLE GEL HOT/COLD PACK | The product contains natural rubber latex but the label states that it does not. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 6, 2021 | Alinity m System, Part No. 08N53-002 | There is an issue with the installation of updated camera firmware on the system. | Class II | Abbott Molecular, Inc. |
| Dec 6, 2021 | Alinity m System, Part No. 08N53-002 | There is a software defect that can cause the Amplification Detection clamp CLEAN position to be ... | Class II | Abbott Molecular, Inc. |
| Dec 6, 2021 | Alinity m System, Part No. 08N53-002 | There is a software issue associated with the ability to properly complete a Field Service Engine... | Class II | Abbott Molecular, Inc. |
| Dec 6, 2021 | Alinity m System, Part No. 08N53-002 | There is a potential for abnormal (non-sigmoidal) amplification curves. | Class II | Abbott Molecular, Inc. |
| Dec 1, 2021 | Michels Transport Medium, 20ML Prefilled Cont | Product stored incorrectly in temperature controlled setting instead of refrigeration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 1, 2021 | Premier Rotaclone, Rx only | Product stored incorrectly in temperature controlled setting instead of refrigeration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 1, 2021 | HARDY DIAGNOSTICS CatScreen, 25dsk/vial | Product stored incorrectly in temperature controlled setting instead of refrigeration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 30, 2021 | Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605 | Affected product was shipped from the warehouse at room temperature instead of the required refri... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 16, 2021 | Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and... | Increase in premature device failures | Class II | Ohio Medical Corporation |
| Nov 3, 2021 | Leica Microsystems M220 F12 Microscope Systems | In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Mi... | Class II | Leica Microsystems, Inc. |
| Nov 2, 2021 | RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-li... | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
| Nov 2, 2021 | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041 | Potential for open packaging seals compromising the sterility of the surgical gowns | Class II | Cardinal Health |
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.