Browse Device Recalls
3,367 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,367 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 3,367 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jan 15, 2021 | ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Produc... | An internal tubing component in the flow path was made with incorrect material which was not test... | Class II | Northgate Technologies, Inc. |
| Jan 15, 2021 | Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 71... | An internal tubing component in the flow path was made with incorrect material which was not test... | Class II | Northgate Technologies, Inc. |
| Jan 7, 2021 | Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, La... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004 | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, La... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG,... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab ... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat,... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium a... | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab C... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, L... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | ChemoPlus" Chemo Prep & Admin Kit, CT4025 | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | The PrisMax System Version II Hemodialysis Delivery System: Automatic Reposit... | Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump As... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2021 | Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, L... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Heal... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... | Class II | Cardinal Health 200, LLC |
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.