Needle, Hypodermic, Single Lumen

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-07-17Open, ClassifiedProcess change control

  Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

  Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

• 2025-07-17Open, ClassifiedProcess change control

  Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

  Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

• 2025-01-03Open, ClassifiedProcess control

  VACUETTE SAFELINK, REF: 450210

  The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.

• 2024-07-23Open, ClassifiedProcess control

  BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/Catalog Number: 320551

  BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.

• 2024-03-14Open, ClassifiedProcess control

  EasyPoint Needle, 25G x 5/8", REF: 82091

  The needle cannula of a retractable needle may detach from the needle holder in the patient.

• 2023-09-29Open, ClassifiedUnder Investigation by firm

  Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G

  19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis

• 2022-07-22Open, ClassifiedProcess change control

  Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga, D015351NK/ BD Needle Kit for Powered Driver 35mm x 15Ga, D015351MK/ BD Manual Driver Needle Kit 35mm x 15Ga, D015451NK/ BD Needle Kit for Powered Driver 45mm x 15Ga, D015451MK/ BD Manual Driver Needle Kit 45mm x 15Ga, D015551NK/ BD Needle Kit for Powered Driver 55mm x 15Ga, D015551MK/ BD Manual Driver Needle Kit 55mm x 15G, D001001/ BD Intraosseous Powered Driver (drill)

  BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.

• 2019-10-31TerminatedNonconforming Material/Component

  BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608

  BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.

• 2017-04-04TerminatedIncorrect or no expiration date

  Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.

  Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.

• 2016-09-22TerminatedUnder Investigation by firm

  MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.

  The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.