N/A 305195Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 30382903051954), received between Nov 15, 2017 and Aug 31, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (28 reports).

3 other recalls cover devices cleared under the same FDA submission (K021475); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Labelling, Instructions for Use or Training Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520503 ↗
• MalfunctionApr 2, 2026Contamination

  IT WAS REPORTED BY A CUSTOMER THAT THEY FOUND A WHITE FLECKS AND A STRAND ON NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24768593 ↗
• MalfunctionMar 24, 2026Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT WHITE SUBSTANCE ON THE NEEDLE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680486 ↗
• MalfunctionMar 24, 2026Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT WHITE SUBSTANCE ON THE NEEDLE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674381 ↗
• MalfunctionNov 13, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD NEEDLE 18X1 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305195. BATCH # 5202809. VERBATIM: PHARMACY TECHNICIAN FOUND NEEDLE CONTAMINATE WITH BLACK SUBSTANCE IN PACKAGING. 18G X1" NEEDLE. LOT 5202809, EXP 07/31/2030.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548975 ↗
• MalfunctionNov 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD NEEDLE 18X1 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305195 BATCH # 4270033 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE USE BD BLUNT FILL NEEDLES AND PRECISION GLIDE NEEDLES WITHIN OUR MANUFACTURING PROCESS AND WANTED TO REACH OUT WITH A QUICK QUESTION FOR YOUR TEAM. AS PART OF AN INTERNAL INVESTIGATION, WE¿RE ASSESSING ALL POSSIBLE SOURCES OF A STAINLESS STEEL PARTICLE THAT WAS RECENTLY OBSERVED DURING PRODUCT INSPECTION. TO HELP RULE OUT POTENTIAL CONTRIBUTORS, COULD YOU PLEASE LET US KNOW IF BD HAS ANY HISTORICAL DATA, COMPLAINTS, OR AWARENESS OF INSTANCES WHERE PARTICULATE SHEDDING OR RESIDUE FROM THE MANUFACTURING PROCESS HAS BEEN OBSERVED ON EITHER OF THESE NEEDLE TYPES? AT THIS STAGE, WE¿RE SIMPLY GATHERING BACKGROUND INFORMATION TO UNDERSTAND WHETHER SUCH OCCURRENCES HAVE EVER BEEN REPORTED OR COULD BE CONSIDERED A POSSIBILITY. THANK YOU VERY MUCH FOR YOUR TIME AND SUPPORT ¿ ANY INFORMATION OR REFERENCES YOU CAN SHARE FROM YOUR QUALITY OR TECHNICAL TEAMS WOULD BE APPRECIATED. ADDITIONAL INFORMATION PROVIDED: CUSTOMER RESPONSE RECEIVED ON 04NOV2025 1. CAN YOU PLEASE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512477 ↗
• MalfunctionJul 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DESCRIPTION: IT WAS REPORTED BY CUSTOMER THEY FOUND BLACK MOLD. VERBATIM: MATERIAL #305195 LOT #4354089 CUSTOMER STATES THAT THEY FOUND BLACK MOLD IN THE SYRINGE AND SOME MOISTURE. THEY FOUND IT BEFORE IT WAS USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410754 ↗
• MalfunctionJul 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DESCRIPTION: IT WAS REPORTED BY CUSTOMER THEY FOUND BLACK MOLD. VERBATIM: MATERIAL #305195. LOT #4354089. CUSTOMER STATES THAT THEY FOUND BLACK MOLD IN THE SYRINGE AND SOME MOISTURE. THEY FOUND IT BEFORE IT WAS USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410746 ↗
• MalfunctionMay 8, 2025Material Perforation; Material Perforation

  MATERIAL # 305195 & BATCH # 4332115. IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE POKED THROUGH PLASTIC CAP. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. ISSUE: NEEDLE POKED THROUGHT PLASTIC CAP. CLEAN NEEDLE STICK OCCURRED. NO, NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED OR REQUESTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21984985 ↗
• MalfunctionDec 18, 2024Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20964391 ↗
• MalfunctionSep 20, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MATERIAL #: 305195, BATCH#: 4150728. IT WAS REPORTED BY CUSTOMER THAT NEEDLES CONTAIN PARTICLE CONTAMINATION SEALED WITHIN THE PACKAGING AND INSIDE THE NEEDLE HUB. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLES CONTAIN PARTICLE CONTAMINATION SEALED WITHIN THE PACKAGING AND INSIDE THE NEEDLE HUB. (B)(6). ITEM - 305195.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266266 ↗
• MalfunctionSep 16, 2024Contamination; Contamination

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 305195. BATCH NUMBER#: 4040631. IT WAS REPORTED BY CUSTOMER THAT FM FOUND ON THE END OF THE NEEDLE. WHITE MATERIAL RCC RECEIVED A COMPLAINT VIA PHONE. REF 305195. LOT: 4040631. ISSUE: FM FOUND ON THE END OF THE NEEDLE. WHITE MATERIAL. DOE: (B)(6) 2024 AND (B)(6) 2024. NO PT HARM FOUND BEFORE INJECTION. SAMPLE IS AVAILABLE. SAMPLE RETURN KIT REQUESTED PLEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224143 ↗
• MalfunctionSep 16, 2024Contamination; Contamination

  MATERIAL#: 305195 BATCH NUMBER#: 4040631. IT WAS REPORTED BY CUSTOMER THAT FM FOUND ON THE END OF THE NEEDLE. WHITE MATERIAL : RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. REF 305195 LOT: 4040631 ISSUE: FM FOUND ON THE END OF THE NEEDLE. WHITE MATERIAL DOE: 28AUG2024 AND 21AUG2024 NO PT HARM FOUND BEFORE INJECTION SAMPLE IS AVAILABLE SAMPLE RETURN KIT REQUESTED, PLEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224118 ↗
• MalfunctionSep 6, 2024Packaging Problem; Packaging Problem

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL# 305195 BATCH# 3209409. IT WAS REPORTED BY CUSTOMER THAT NEEDLES IS NOT IN SEALED PACKAGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLES IS NOT IN SEALED PACKAGE FOR BD 18GX1" NEEDLE; LOT#:3209409, EXP: 9/30/28, REF#: 305195.

  Patient problems: Insufficient Information

  MAUDE report 20155850 ↗
• MalfunctionSep 3, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL # 305195; BATCH # 4060183. IT WAS REPORTED BY CUSTOMER THAT NEEDLE WAS IN A SEALED PACKAGE, NO LID AND APPEARS TO HAVE RUST PARTICULATES ON IT. VERBATIM: I WANTED TO PASS ALONG A NEEDLE WE FOUND IN OUR IV ROOM LAST NIGHT. THIS NEEDLE WAS IN A SEALED PACKAGE, NO LID AND APPEARS TO HAVE RUST PARTICULATES ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129287 ↗
• MalfunctionAug 20, 2024Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  MATERIAL #: 305195 BATCH#: 4031647, 4060185. IT WAS REPORTED BY CUSTOMER THAT BLACK CONTAMINANT INSIDE THE COVER OF THE NEEDLE. 4 DIFFERENT NEEDLES WERE FOUND TO BE CONTAMINATED. ONE LOT IS LISTED ABOVE, THE OTHER IS 4031647 EXP 5-31-29. UNABLE TO USE PRODUCT. WE DID NOT TRUST THE STERILITY OF THIS ITEM. PRODUCT#: 305195. VERBATIM: RCC RECEIVED A COMPLAINT VIA COMMUNITY. BLACK CONTAMINANT INSIDE THE COVER OF THE NEEDLE. 4 DIFFERENT NEEDLES WERE FOUND TO BE CONTAMINATED. ONE LOT IS LISTED ABOVE, THE OTHER IS 4031647 EXP 5-31-29. UNABLE TO USE PRODUCT. WE DID NOT TRUST THE STERILITY OF THIS ITEM. PRODUCT#: 305195.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005847 ↗
• MalfunctionAug 12, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT DD-MMM-YYYY? PRODUCT WAS RECEIVED 25/07/2024, DEFECTIVE PRODUCT WAS FOUND THE SAME DAY. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THIS WAS FOUND ON OUR INCOMING AREA. THEREFORE, IT WAS NEVER USED IN A PATIENT. MATERIAL # 305195; BATCH # 4150728. IT WAS REPORTED BY CUSTOMER THAT PRODUCT HAS EXCESSIVE RESIDUE OF GLUE ON THE HUB. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT 305195 HAS BEEN REJECTED IN OUR INCOMING RECEIVING AREA BY OUR QUALITY TEAM FOR THE BELOW REASON: PRODUCT HAS EXCESSIVE RESIDUE OF GLUE ON THE HUB. SAMPLES AVAILABLE. BUSSE ITEM# 8080A-1. BD ITEM# 305195- 18 GAUGE X 1" NEEDLE. LOT# 4150728. (B)(4). QTY REJECTED 2 CASES (B)(4) PCS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968302 ↗
• MalfunctionAug 12, 2024Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION RECEIVED. PLEASE CONFIRM WHETHER THERE WAS ANY PATIENT IMPACT. NOT THAT WE ARE AWARE OF ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO THERE WAS NOT. MATERIAL#: 305195, BATCH#: 4031647. IT WAS REPORTED BY CUSTOMER THAT THIS WEEKEND OUR STAFF DISCOVERED A BLACK SPOT/FLECK(S) ON THE INSIDE TIP OF THE BEVEL OF SOME BD 18GA PRECISION GLIDE NEEDLES. ONE OF OUR TECHNICIANS RUBBED OFF THE MATERIAL USING THE NEEDLE COVER (SEE PICTURE TO THE RIGHT). ALSO ATTACHED ARE TWO PICTURES SHOWING THE INSIDE BEVEL OF THE NEEDLE WHERE THE BLACK MARK IS. THESE WERE ALL FROM LOT#: 4031647 AND WE HAVE THEM SEQUESTERED CURRENTLY. COMPLAINT RECEIVED VIA EMAIL(S). RCC RECEIVED A COMPLAINT VIA EMAIL. THIS WEEKEND OUR STAFF DISCOVERED A BLACK SPOT/FLECK(S) ON THE INSIDE TIP OF THE BEVEL OF SOME BD 18GA PRECISIONGLIDE NEEDLES. ONE OF OUR TECHNICIANS RUBBED OFF THE MATERIAL USING THE NEEDLE COVER (SEE PICTURE TO THE RIGHT). ALSO ATTACHED ARE TWO PICTURES SHOWING THE INSIDE BEVEL OF THE NEEDLE WHERE THE BLACK MARK IS. THESE WERE ALL FROM LOT#: 4031647 AND WE HAVE THEM SEQUESTERED CURRENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968197 ↗
• MalfunctionAug 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED. MATERIALS#: 305195, BATCH#: 4040643. IT WAS REPORTED BY THE CUSTOMER THAT CONTAMINATION INSIDE THE STERILE PACKAGING OF NEEDLE. VERBATIM: CONTAMINATION INSIDE THE STERILE PACKAGING OF NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905313 ↗
• MalfunctionAug 1, 2024Contamination; Contamination

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL #: 305195. BATCH #: 4031647. IT WAS REPORTED BY THE CUSTOMER THAT THERE ARE BLACK FLECKS ALONG INSIDE OF THE NEEDLE CAP - UNOPENED PACKAGING - CAN SEE BLACK FLECK ALONG THE INSIDE OF CAP. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. THERE ARE BLACK FLECKS ALONG INSIDE OF THE NEEDLE CAP - UNOPENED PACKAGING - CAN SEE BLACK FLECK ALONG THE INSIDE OF CAP. NO IMPACT - NEEDLES USED IN COMPOUNDING ENVIRONMENT AND NO DIRECT PATIENT CONTACT. PRODUCT CODE: 305195.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19883694 ↗
• MalfunctionApr 26, 2024Material Puncture/Hole; Material Puncture/Hole

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL # 305195. BATCH # 3158795. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE PIERCING OUT OF THE PLASTIC COVER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON 19/04/2024 WHILE MIXING INSIDE THE CLEANROOM , WE FOUND 1 OF BD NEEDLE REF# (B)(4) LOT# 3158795 WITH THE NEEDLE PIERCING OUT OF THE PLASTIC COVER . ITEM CANNOT BE USED. WE HAVE RECEIVED PRODUCT COMPLAINT REGARDING THE ITEM# (B)(4) ITEM DESCRIPTION: NEEDLE BD HYPO 18GX1IN STERILE. LOT # 3158795.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193741 ↗
• MalfunctionApr 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL# (B)(4) BATCH# 3299631 IT WAS REPORTED BY CUSTOMER THAT THE PHARMACY TECHNICIANS FOUND BLACK PARTICLES IN THE STERILE PACKAGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED PRODUCT COMPLAINT - CUSTOMER CALLED TO REPORT THAT ONE OF THE PHARMACY TECHNICIANS FOUND BLACK PARTICLES IN THE STERILE PACKAGE OF THE 18 G X 1 IN BD PRECISIONGLIDE¿ NEEDLE - 305195 LOT 3299631, THERE ARE SEVERAL NEEDLES IN THE PACKAGE WITH THIS ISSUE THROUGH OUT THE PHARMACY AND THE LOT IN STOCK HAS BEEN SEQUESTERED. SAMPLE IS AVAILABLE, NO PT HARM, DATE OF EVENT (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050202 ↗
• MalfunctionApr 1, 2024Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL#: 305195, BATCH NUMBER#: 3233736. IT WAS REPORTED BY CUSTOMER THAT FOUND A 18G BD NEEDLE WITH ODD DOTS ALL ACROSS THE SURFACE. THE DOTS ARE NOT A PART OF THE THIN PLASTIC PACKAGING, BUT RATHER ON THE NEEDLE ITSELF. IT MAY POSSIBLY BE INK OR SOME OTHER RESIDUE, BUT IT DID NOT SEEM SAFE OR STERILE TO USE. IN CONJUNCTION WITH THE 18G BD NEEDLE WITH A PIECE OF HAIR IMBEDDED INTO THE PACKAGING WAS ALSO FOUND A FEW WEEKS AGO, IT DOES RAISE QUESTIONS ABOUT THE CURRENT MANUFACTURING PRACTICES WITH THESE NEEDLES. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. OVER THE WEEKEND IV ROOM PHARMACY TECH FOUND A 18G BD NEEDLE WITH ODD DOTS ALL ACROSS THE SURFACE. THE DOTS ARE NOT A PART OF THE THIN PLASTIC PACKAGING, BUT RATHER ON THE NEEDLE ITSELF. IT MAY POSSIBLY BE INK OR SOME OTHER RESIDUE, BUT IT DID NOT SEEM SAFE OR STERILE TO USE. IN CONJUNCTION WITH THE 18G BD NEEDLE WITH A PIECE OF HAIR IMBEDDED INTO THE PACKAGING WAS ALSO FOUND A FEW WEEKS AGO, IT DOES RAISE QUESTIONS ABOUT THE CURRENT MANUFACTURING PRACTICES WITH THESE NEEDLES. I HAVE A SAMPLE OF THE PRODUCT IN MY OFFICE. LOT NUMBER IS 3233736. RESPONSE: UNFORTUNATELY, THE N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011038 ↗
• MalfunctionFeb 15, 2024Defective Device; Defective Device

  MATERIALS#: 305195 BATCH#: 2363714 IT WAS REPORTED BY THE CUSTOMER THAT CORING IS OCCURRING WHEN THEY ARE INSERTING IN MEDICATION VIALS. RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT-MDS FACILITY: (B)(6) REF: 305196 REF 305196 LOT: 2ND 3271842 ISSUE: CORING IS OCCURRING WHEN THEY ARE INSERTING IN MEDICATION VIALS. DOE: UNKNOWN PT HARM: NO SAMPLE: REPRESENTATIVE SAMPLES AVAILABLE THIS CASE IS RELATED TO (B)(4) WHEN THIS GETS TRANSITIONED INTO TW PLEASE RELATE THE CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712215 ↗
• MalfunctionFeb 13, 2024Defective Component; Defective Component

  ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 305195. BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT DESCRIPTION OF COMPLAINT: THIS SYRINGE CAME OUT OF THE PACKAGE/BOX IN THIS FORMAT (SEE PICTURE BELOW) AND CUT MY SONOGRAPHER. STAFF MEMBER WAS POKED, NO PATIENT INVOLVEMENT. STAFF MEMBER FILLED OUT AN INCIDENT REPORT INDICATING ¿NEEDLE STICK INJURY ¿ FROM INCORRECT PACKAGING¿. IN HIS REPORT HE INDICATES APPLYING AN 18G BD PRECISION GLIDE NEEDLE TO A SYRINGE FOR MAKING ¿FLUSHES¿ WHEN HE WAS POKED. THE NEEDLE WAS POKING OUT THROUGH THE PLASTIC COVER AND WRAPPER. PUNCTURED HIS FINGER CAUSING BLEEDING FOR 5-10 MINUTES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DESCRIPTION OF COMPLAINT: THIS SYRINGE CAME OUT OF THE PACKAGE/BOX IN THIS FORMAT (SEE PICTURE BELOW) AND CUT MY SONOGRAPHER. STAFF MEMBER WAS POKED, NO PATIENT INVOLVEMENT. STAFF MEMBER FILLED OUT AN INCIDENT REPORT INDICATING ¿NEEDLE STICK INJURY ¿ FROM INCORRECT PACKAGING¿. IN HIS REPORT HE INDICATES APPLYING AN 18G BD PRECISION GLIDE NEEDLE TO A SYRINGE FOR MAKING ¿FLUSHES¿ WHEN HE WAS POKED. THE NEEDLE WAS POKING OUT THROUGH THE PLASTIC COVER AND WRAPPER. PUNCTURED HIS FINGER CAUSING BLEEDING FOR 5-10

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18698255 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021475. One submission often covers many models, so check the product and lot details in each record.

• Z-0588-2021 · Nov 18, 2020 · Terminated
  BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the bo
• Z-0207-2018 · May 31, 2017 · Terminated
  BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain bl
• Z-1009-2012 · Oct 8, 2011 · Terminated
  BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications