BD Nano 2nd Gen 320551Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 30382903205517), received between Sep 29, 2020 and Jun 10, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Defective Device” (12 reports).

2 other recalls cover devices cleared under the same FDA submission (K212015); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Defective Device; Defective Device

  SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE.  THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024 LOT # UNKNOWN AT THIS TIME. CATALOG# UNKNOWN PEN NEEDLE SAMPLE PACKETS AT THIS TIME. DATE OF EVENT UNKNOWN. SAMPLE STATUS UNKNOWN. TMAIK 07JUNE2024. EMBECTA WAS INFORMED BY OUR DISTRIBUTOR RR DONNELLEY THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY RR DONNELLEY. TMAIK 10JUNE2024: ¿TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506239 ↗
• MalfunctionJun 10, 2024Defective Device; Defective Device

  SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE.  THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024 - DC. LOT # UNKNOWN AT THIS TIME. CATALOG# UNKNOWN PEN NEEDLE SAMPLE PACKETS AT THIS TIME. DATE OF EVENT UNKNOWN . SAMPLE STATUS UNKNOWN. TMAIK 06JUNE2024. EMBECTA WAS INFORMED BY OUR DISTRIBUTOR RR DONNELLEY THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY (B)(6). TMAIK 10JUNE2024: TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506100 ↗
• MalfunctionJun 10, 2024Expiration Date Error; Defective Device; Expiration Date Error; Defective Device

  SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE. THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024. LOT # UNKNOWN AT THIS TIME. CATALOG# UNKNOWN PEN NEEDLE SAMPLE PACKETS AT THIS TIME. DATE OF EVENT UNKNOWN . SAMPLE STATUS UNKNOWN. TMAIK 07JUNE2024: EMBECTA WAS INFORMED BY OUR DISTRIBUTOR (B)(6) THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY (B)(6). TMAIK 10JUNE2024: ¿TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505701 ↗
• MalfunctionJun 10, 2024Expiration Date Error; Defective Device; Expiration Date Error; Defective Device

  SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE. THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024 . LOT # UNKNOWN AT THIS TIME. CATALOG# UNKNOWN PEN NEEDLE SAMPLE PACKETS AT THIS TIME. DATE OF EVENT UNKNOWN , SAMPLE STATUS UNKNOWN. TMAIK 07JUNE2024. EMBECTA WAS INFORMED BY OUR DISTRIBUTOR (B)(4) THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY (B)(4). TMAIK 10JUNE2024: ¿TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505669 ↗
• MalfunctionJun 10, 2024Expiration Date Error; Defective Device; Expiration Date Error; Defective Device

  SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE. THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024 LOT # UNKNOWN AT THIS TIME. CATALOG# UNKNOWN PEN NEEDLE SAMPLE PACKETS AT THIS TIME. DATE OF EVENT UNKNOWN . SAMPLE STATUS UNKNOWN. TMAIK 07JUNE2024: EMBECTA WAS INFORMED BY OUR DISTRIBUTOR (B)(6) THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY (B)(6). TMAIK 10JUNE2024: ¿TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505612 ↗
• MalfunctionJun 10, 2024Expiration Date Error; Defective Device; Expiration Date Error; Defective Device

  SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE. THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024 - LOT # UNKNOWN AT THIS TIME. CATALOG# UNKNOWN PEN NEEDLE SAMPLE PACKETS AT THIS TIME. DATE OF EVENT UNKNOWN . SAMPLE STATUS UNKNOWN. TMAIK 07JUNE2024 EMBECTA WAS INFORMED BY OUR DISTRIBUTOR (B)(6) THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY (B)(6). TMAIK 10JUNE2024: ¿TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505609 ↗
• MalfunctionJun 10, 2024Expiration Date Error; Defective Device; Expiration Date Error; Defective Device

  SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE. THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024 LOT # UNKNOWN AT THIS TIME. CATALOG# UNKNOWN PEN NEEDLE SAMPLE PACKETS AT THIS TIME. DATE OF EVENT UNKNOWN . SAMPLE STATUS UNKNOWN. TMAIK 07JUNE2024 EMBECTA WAS INFORMED BY OUR DISTRIBUTOR (B)(6) THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY (B)(6). TMAIK 10JUNE2024: ¿TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505604 ↗
• MalfunctionJun 10, 2024Defective Device; Defective Device

  SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE. THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024 LOT # UNKNOWN AT THIS TIME CATALOG# UNKNOWN PEN NEEDLE SAMPLE PACKETS AT THIS TIME DATE OF EVENT UNKNOWN . SAMPLE STATUS UNKNOWN. (B)(6) 10JUNE2024 EMBECTA WAS INFORMED BY OUR DISTRIBUTOR (B)(4) THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY (B)(4). (B)(6) 10JUNE2024: ¿TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505585 ↗
• MalfunctionJun 10, 2024Defective Device; Defective Device

  SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE. THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024 LOT # UNKNOWN AT THIS TIME CATALOG# UNKNOWN PEN NEEDLE SAMPLE PACKETS AT THIS TIME DATE OF EVENT UNKNOWN. SAMPLE STATUS UNKNOWN. (B)(6) 07JUNE2024 EMBECTA WAS INFORMED BY OUR DISTRIBUTOR (B)(4) THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY (B)(4). (B)(6) 10JUNE2024: ¿TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505549 ↗
• MalfunctionJun 10, 2024Defective Device; Defective Device

  SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE. THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024 LOT # UNKNOWN AT THIS TIME CATALOG# UNKNOWN PEN NEEDLE SAMPLE PACKETS AT THIS TIME DATE OF EVENT UNKNOWN SAMPLE STATUS UNKNOWN TMAIK 10JUNE2024 EMBECTA WAS INFORMED BY OUR DISTRIBUTOR RR DONNELLEY THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY RR DONNELLEY. TMAIK 10JUNE2024: ¿TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505514 ↗
• MalfunctionJun 10, 2024Defective Device; Defective Device

  SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE. THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024. TMAIK 07JUNE2024: EMBECTA WAS INFORMED BY OUR DISTRIBUTOR RR DONNELLEY THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY RR DONNELLEY. TMAIK 10JUNE2024: ¿TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505489 ↗
• MalfunctionJun 10, 2024Defective Device; Defective Device

  SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE.  THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024 LOT # UNKNOWN AT THIS TIME CATALOG# UNKNOWN PEN NEEDLE SAMPLE PACKETS AT THIS TIME DATE OF EVENT UNKNOWN SAMPLE STATUS UNKNOWN TMAIK 10JUNE2024 EMBECTA WAS INFORMED BY OUR DISTRIBUTOR RR DONNELLEY THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY RR DONNELLEY. TMAIK 10JUNE2024: ¿TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505432 ↗
• MalfunctionApr 15, 2024Misconnection; Misconnection

  CONSUMER REPORTED WHEN INJECTING WITH THE 2ND GEN PEN NEEDLES ONLY, THE NEEDLE REALLY HURTS GOING INTO THE SITE AND COMING OUT OF THE SITE. DOES A FLOW CHECK WITH EACH INJECTION. DC. CONSUMER REPORTED - 2 PEN NEEDLES HARD TO ATTACH ONTO HIS PEN. LOT#: 1173074, CATALOG#: 320551 - SAMPLE PACK, DATE OF EVENT: 03-22-2024, SAMPLE STATUS: AWAITING SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111738 ↗
• MalfunctionSep 29, 2020Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT DURING PRIMING WITH A BD NANO¿ 2ND GEN PEN NEEDLE THE INSULIN DOES NOT FLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN PRIMING, NO INSULIN FLOWS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10603615 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K212015. One submission often covers many models, so check the product and lot details in each record.

• Z-2424-2024 · Jun 18, 2024 · Open, Classified
  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
• Z-3179-2026 · Jul 26, 2023 · Open, Classified
  EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100