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 |
|---|---|---|---|---|
| Sep 14, 2022 | Prismaflex HF20 Set (product code 109841). For use in providing continuous f... | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... | Class II | Baxter Healthcare Corporation |
| Sep 9, 2022 | MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632 | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 9, 2022 | MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592 | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 9, 2022 | MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756 | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 9, 2022 | MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561 | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 9, 2022 | MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245 | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 7, 2022 | CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545 | One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 2, 2022 | Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code C... | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barc... | Class III | Baxter Healthcare Corporation |
| Sep 1, 2022 | VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular proc... | Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #1... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. ... | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 19, 2022 | Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1... | Reports received of an increase of message code 9186 (internal control failed) when using the kit. | Class II | Abbott Molecular, Inc. |
| Aug 12, 2022 | SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Ba... | Potential presence of residual adhesive material on the mesh surface. | Class II | Chamberlain Technologies LLC |
| Aug 12, 2022 | SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number... | Potential presence of residual adhesive material on the mesh surface. | Class II | Chamberlain Technologies LLC |
| Aug 12, 2022 | SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Ca... | Potential presence of residual adhesive material on the mesh surface. | Class II | Chamberlain Technologies LLC |
| Aug 12, 2022 | SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog ... | Potential presence of residual adhesive material on the mesh surface. | Class II | Chamberlain Technologies LLC |
| Aug 9, 2022 | Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product C... | Firm noted an increase in customer reports of leaks. | Class I | Baxter Healthcare Corporation |
| Aug 3, 2022 | MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 1... | Potential for the suction catheter to come apart from the green connector near the thumb valve. T... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2022 | MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch... | Potential for the suction catheter to come apart from the green connector near the thumb valve. T... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2022 | MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 1... | Potential for the suction catheter to come apart from the green connector near the thumb valve. T... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 26, 2022 | ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 | One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking age... | Class II | Abbott Laboratories |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, RE... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100 | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, ... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack,... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 p... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 19, 2022 | The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. | Incorrect optical calibration | Class II | Abbott Molecular, Inc. |
| 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 |
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.