Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 326 - 350 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Halyard, Eye Bag Pack. Kit Code: UIEB48-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization.	FDA Z-2410-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 30, 2026	Details
Hintermann Series Talar Implant, Left, Size 2 REF 302112 Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.	FDA Z-2399-2026	Medical Device	High	Jun 17, 2026 Recall: Mar 24, 2026	Details
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure. Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.	FDA Z-2413-2026	Medical Device	High	Jun 17, 2026 Recall: May 12, 2026	Details
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.	FDA Z-2341-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 30, 2026	Details
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.	FDA Z-2354-2026	Medical Device	High	Jun 17, 2026 Recall: May 1, 2026	Details
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.	FDA Z-2351-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 30, 2026	Details
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G; Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.	FDA Z-2321-2026	Medical Device	High	Jun 17, 2026 Recall: May 12, 2026	Details
Halyard, Drape Pack. Kit Code: LMDP36-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization.	FDA Z-2409-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 30, 2026	Details
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.	FDA Z-2345-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 30, 2026	Details
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.	FDA Z-2350-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 30, 2026	Details
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.	FDA Z-2340-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 30, 2026	Details
Plum Duo Precision IV Pump, 40002-0403 Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.	FDA Z-2313-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 29, 2026	Details
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.	FDA Z-2342-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 30, 2026	Details
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.	FDA Z-2333-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 30, 2026	Details
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.	FDA Z-2336-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 30, 2026	Details
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, C Due to incorrect incubation process being performed on product.	FDA Z-2332-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 13, 2026	Details
Allia IGS 5 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.	FDA Z-2315-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 20, 2026	Details
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.	FDA Z-2398-2026	Medical Device	High	Jun 17, 2026 Recall: May 7, 2026	Details
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930 Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.	FDA Z-2327-2026	Medical Device	High	Jun 17, 2026 Recall: May 1, 2026	Details
Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45 mm (0.0175 in) REF: TCN-5-3m, TCN Electrode, NITINOL, 3M CABLE, 5 cm x 0.45 mm (0.0175 in) REF: TCN-10-3M, TCN Electrode, NITINOL, 3M CABLE, 10 cm x 0.45 mm (0.0175 in); REF: TCN-15-3M, TCN Electrode, NITINOL, 3M CABLE, 15 cm x 0.45 mm (0.0175 in) REF: TCN-20-3M, TCN Electrode, NITINOL, 3M CABLE, 20 cm x 0.45 mm (0.0175 in Reusable electrodes may not meet expected performance levels.	FDA Z-2403-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 29, 2026	Details
MOSAIQ Oncology Information System Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.	FDA Z-2406-2026	Medical Device	High	Jun 17, 2026 Recall: May 21, 2026	Details
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, C Due to incorrect incubation process being performed on product.	FDA Z-2331-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 13, 2026	Details
Allia Moveo angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.	FDA Z-2318-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 20, 2026	Details
Halyard, Pain Pack. Kit Code: AMPK48-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization.	FDA Z-2407-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 30, 2026	Details
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00; An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.	FDA Z-2324-2026	Medical Device	High	Jun 17, 2026 Recall: Apr 30, 2026	Details

Showing 326 - 350 of 1,678 product recalls

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Medical Device Recalls Today

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How To Check Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

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Follow The Official Remedy

Use the linked official notice for final instructions such as repair, replacement, refund, disposal, software update, stop-use or company contact.