Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 76 - 100 of 2,579 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30. A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.	FDA Z-0283-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 8, 2026	Details
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.	FDA Z-0126-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 17, 2026	Details
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216; Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC iX).	FDA Z-0199-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.	FDA Z-0272-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 9, 2026	Details
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130; Material Number: M001195740 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0257-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
PNE Lead Implant Kit REF: 1701 Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.	FDA Z-0198-2027	Medical Device	High	Oct 28, 2026 Recall: Jul 15, 2024	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155; Material Number: M001195250 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0228-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068. Potential for leakage and backflow at the Safsite valve.	FDA Z-0193-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 14, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155; Material Number: M001195310 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0234-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0247-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Think Surgical Square Driver REF: 109126 Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.	FDA Z-0192-2027	Medical Device	High	Oct 28, 2026 Recall: Aug 20, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130; Material Number: M001195410 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0240-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M; 3) TAH PACK, Medline Kit Number/SKU DYNJ60646A; 4) TUBAL LIGATION RFD, Medline Kit Number/SKU DYNJ906291F. Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.	FDA Z-0277-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 9, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155; Material Number: M001195220 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0225-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.	FDA Z-0128-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 17, 2026	Details
CareLink Clinic, REF: MMT-7350 CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting insulin. Instead, the calculator continues to use the system-recommended values, resulting in incorrect rapid-acting insulin parameters. If an HCP or patient inputs these incorrect setting values into the patient's MiniMed Go app, the patient could deliver higher or lower insulin doses compared to their insulin needs, potentially leading to over/under delivery of insulin with a severity ranging from Catastrophic (death from severe hypoglycemia) to Minor (self-treatable hypoglycemia/hyperglycemia).	FDA Z-0203-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 11, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number: M001195200 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0223-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155; Material Number: M001195420 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0241-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155; Material Number: M001195350 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0238-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number: M001195940 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0263-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130; Material Number: M001195910 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0262-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155; Material Number: M001195450 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0244-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number: M001195230 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0226-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
MEDLINE medical convenience kits labeled as: (list truncated) Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.	FDA Z-0278-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 9, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0233-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details

Showing 76 - 100 of 2,579 product recalls

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Medical Device Recalls Today

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Recall Class And Risk Level

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

Match The Exact Medical device

Use each recall result to compare device name, company, product code, model, serial, lot number, UDI and software version. A similar name is not enough; recalls often apply only to specific versions or production ranges.

Read The Recall Hazard

Check the notice for FDA recall class, patient risk, correction, removal and clinical action. This helps you decide whether the item should be stopped immediately or handled through a normal remedy process.

Check Where It Was Sold

Review retailer, online marketplace, state, distribution and purchase-date details when they are available. Some recalls apply only to certain stores or channels.

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.