Alaris 8975 (UDI 10885403897504)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10885403897504), received between Nov 28, 2018 and Feb 8, 2023 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (15 reports).

5 other recalls cover devices cleared under the same FDA submission (K072105); 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2023Computer System Security Problem; Appropriate Device Problem Term/Code Not Available; Computer System Security Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PRODUCT SECURITY ISSUES WERE FOUND DURING A PENETRATION TEST ON ALARIS SYSTEMS MANAGER PERFORMED BY THE CUSTOMER. THE TEST WAS PERFORMED PRIOR TO GO-LIVE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16319998 ↗
• MalfunctionNov 8, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLE WAS UNABLE TO ATTACH TO THE INSULIN PEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE NEEDLE HUB WILL NOT ATTACH ONTO THE INSULIN PEN BECAUSE IT IS NOT PROPERLY THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15753546 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLE EXPERIENCED THE CANNULA BREAKING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING ONE OF THE 25 PEN NEEDLES SUPPLIED WITH THE END NEEDLE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610722 ↗
• MalfunctionOct 14, 2022Misconnection; Misconnection

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLE WAS UNABLE TO ATTACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING A PEN NEEDLE THAT WOULD NOT ATTACH TO PEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610170 ↗
• MalfunctionFeb 28, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT 1 BD¿ ULTRA-FINE¿ MINI PEN NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO INSULIN FLOW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625625 ↗
• MalfunctionJan 5, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHEN USING THE UNSPECIFIED BD MINI PEN NEEDLES, THE DEVICE EXPERIENCED THE INABILITY TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: I RECEIVED A PHONE CALL FROM A XXXXXXXX, STATING THAT OVER THE PAST TWO YEARS SHE HAS HAD ISSUES WITH THE MINI PEN NEEDLES. THE ISSUE IS WHEN SHE IS PRIMING THE PEN NEEDLE NOTHING COMES OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172117 ↗
• MalfunctionNov 23, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT 2 BD 31GA PEN NEEDLE WERE UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, WHEN TRYING TO TAKE INSULIN, THE FLOW STOPPED BEFORE HE WAS DONE WITH INJECTION. STATED, HE HAD TO USE A SECOND, THEN 3RD PEN NEEDLE BEFORE HE WAS ABLE TO COMPLETE HIS FULL DOSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866347 ↗
• MalfunctionOct 12, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED PEN NDL 31G 5MM WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...REPORTED FINDING CLOGGED PEN NEEDLES DURING INJECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619731 ↗
• MalfunctionApr 1, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY HAD A MIX OF PRODUCT TYPE IN PACK BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER RECEIVED A BOX OF NEEDLES WITH TWO DIFFERENT LOT#. THE LOT#9165998 IS THE LOT# THEY SHOULD HAVE RECIEVED. VERBATIM: FROM PHONE CALL ON 2021-03-11 17:39:19: STATED, TWO DIFFERENT LOTS IN ONE BOX 1 PEN NEEDLE AFFECTED, SAMPLE: YES, CATALOG: 320882 CL. PIR ATTACHED TO FILE AND EMAIL INFORMATION IS COPIED AND PASTED BELOW: EMAIL RECEIVED¿2021-03-08 12:49:5CUSTOMER CALLED STATING HE RECEIVED 2 DIFFERENT NEEDLES WITH LOT 3122271, IN THE SAME BOX OF NEEDLES THAT ARE LOT 9165998. THE LOT 9165998 IS THE LOT HE SHOULD HAVE RECEIVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11601748 ↗
• MalfunctionOct 7, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY HAD NO EXPIRATION DATE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320882 BATCH NO. 5006486, UNKNOWN (PROVIDED: 8015571). IT WAS REPORTED THAT THERE IS NO EXPIRATION DATE ON SHELF CARTONS. VERBATIM: CONSUMER CALLED TO INQUIRE ABOUT PEN NEEDLE EXPIRATION DATE. STATED THERE IS NO EXPIRATION DATE ON THE PRODUCT BOX. CONSUMER ALSO COULD NOT LOCATE A COPYRIGHT DATE. CONSUMER STATED SHE DID USE SOME OF THESE PEN NEEDLES. INFORMED THAT THESE COULD BE EXPIRED AND THAT BD TESTS THE PRODUCTS FOR 5 YEARS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10646461 ↗
• MalfunctionSep 22, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED UPON REMOVING THE TEAR DROP LABEL FROM ONE PEN NEEDLE, THERE IS SOMETHING SMALL AND RED THAT HE CAN SEE IN THE NEEDLE HUB. STATED IT ALMOST LOOKS LIKE A BUG. LOT #: 9114904. CATALOG#: 320882. DATE OF EVENT: 08/30/20.

  Patient problems: No Patient Involvement

  MAUDE report 10564984 ↗
• MalfunctionJul 3, 2020Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320882 BATCH NO: 9114903. CONSUMER REPORTED NO INSULIN FLOW DURING INJECTION. CONSUMER IS NEW TO USING PEN NEEDLES, DOES NOT RE-USE. DATE OF EVENT: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10228201 ↗
• MalfunctionJun 22, 2020Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT NO INSULIN WOULD FLOW THROUGH THE BD ULTRA-FINE¿ INSULIN PEN NEEDLE DURING THE PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED WHEN PRIMING, NO INSULIN FLOWS, SO SHE HAS TO USE A SECOND PEN NEEDLE TO GET IT TO WORK. STATED, IF IT DOES NOT PRIME, SHE WILL NOT TRY TO INJECT WITH IT"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10182004 ↗
• MalfunctionDec 3, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT HAS BEEN REPORTED THAT THE BD¿ PEN NDL 31G 5MM 90CT HAS BEEN FOUND WITH A LOOSE OUTER COVER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE OUTER COVER IS LOOSE, MAKING IT DIFFICULT TO REMOVE THE NEEDLE FROM THE PEN AFTER INJECTION. THAT THE OUTER COVER IS LOOSE, MAKING IT DIFFICULT TO REMOVE THE NEEDLE FROM THE PEN AFTER INJECTION. VERBATIM: CONSUMER REPORTED THAT THE OUTER COVER IS LOOSE, MAKING IT DIFFICULT TO REMOVE THE NEEDLE FROM THE PEN AFTER INJECTION. CONSUMER STATED THAT HE STUCK HIS FINGER WHILE TRYING TO REMOVE THE NEEDLE FROM THE PEN AND BLEEDING OCCURRED, NO MEDICAL ATTENTION SOUGHT. LOT # 8074601. PRODUCT # 320883. EXP 03-31-2023. INCIDENT DATE UNKNOWN. OCCURRENCE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9405776 ↗
• MalfunctionOct 30, 2019Failure to Deliver; Failure to Deliver

  IT HAS BEEN REPORTED THAT THE PEN NDL 31G 5MM 90 COUNT HAS BEEN FOUND EXPERIENCING INABILITY TO DELIVER MEDICATION DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320882 BATCH NO. UNKNOWN. IT WAS REPORTED THAT NEEDLE CLOGGED DURING INJECTION. VERBATIM: CONSUMER REPORTED, LAST NIGHT WHEN HE WAS OUT TO DINNER, HE DIALED UP 40 UNITS AND ONLY 16 UNITS CAME OUT. STATED, HE WASTED 5 PEN NEEDLES THAT NIGHT AND DID NOT COMPLETE DOSAGE UNTIL 6TH PEN NEEDLE DOES NOT PRIME BEFORE INJECTION BECAUSE HE DOES NOT WANT TO WASTE INSULIN. ITEM: 320882. DISCARDED SAMPLES. STATED, IN THE PAST, HE'S HAD PEN NEEDLES THAT WOULD NOT RELEASE INSULIN DURING INJECTION. OCCURRED WITH DIFFERENT LOT'S BUT COULD NOT PROVIDE INCIDENT DATES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9256697 ↗
• MalfunctionOct 30, 2019Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE CONSUMER WENT THROUGH 5 BD ULTRA-FINE¿ INSULIN PEN NEEDLES ATTEMPTING TO INJECT A TOTAL OF "40 UNITS" OF INSULIN DURING USE. THE FIRST ONLY DISPENSED "16 UNITS", AND THE SUBSEQUENT NEEDLES WERE USED UNTIL THE FULL DOSAGE WAS RECEIVED. THE CONSUMER REPORTEDLY DID NOT PRIME ANY NEEDLES BEFOREHAND DUE TO "NOT WANTING TO WASTE INSULIN". THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED, LAST NIGHT WHEN HE WAS OUT TO DINNER, HE DIALED UP 40 UNITS AND ONLY 16 UNITS CAME OUT. STATED, HE WASTED 5 PEN NEEDLES THAT NIGHT AND DID NOT COMPLETE DOSAGE UNTIL 6TH PEN NEEDLE. DOES NOT PRIME BEFORE INJECTION BECAUSE HE DOES NOT WANT TO WASTE INSULIN."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9255592 ↗
• MalfunctionOct 11, 2019Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT 5 PEN NDL 31G 5MM EXPERIENCED INABILITY OR DIFFICULT TO PRIME DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320882. BATCH NO. 8231386. ISSUE(S): NEEDLE CLOGGED DURING FLOW CHECK WITH INSULIN. FOUND 5 PEN NEEDLES DATE OF EVENT: UNKNOWN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9180457 ↗
• MalfunctionSep 24, 2019Misconnection; Failure to Deliver; Misconnection; Failure to Deliver

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN PEN NEEDLE HAD NO INSULIN FLOW DURING THE INJECTION. THE PEN NEEDLE WAS REPORTEDLY NOT PRIMED BEFORE USE. LOT # 8078465 AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED: NO INSULIN FLOW DURING INJECTION. DOES NOT PRIME BEFORE USE. SHE EXPERIENCED THIS ISSUE WITH 2 BOXES. STATED, WASTING A LOT OF PEN NEEDLES".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9110485 ↗
• MalfunctionSep 24, 2019Misconnection; Failure to Deliver; Misconnection; Failure to Deliver

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN PEN NEEDLE HAD NO INSULIN FLOW DURING THE INJECTION. THE PEN NEEDLE WAS REPORTEDLY NOT PRIMED BEFORE USE. LOT # 8078465 AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED: NO INSULIN FLOW DURING INJECTION DOES NOT PRIME BEFORE USE SHE EXPERIENCED THIS ISSUE WITH 2 BOXES STATED, WASTING A LOT OF PEN NEEDLES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9110349 ↗
• MalfunctionSep 24, 2019Misconnection; Failure to Deliver; Misconnection; Failure to Deliver

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN PEN NEEDLE HAD NO INSULIN FLOW DURING THE INJECTION. THE PEN NEEDLE WAS REPORTEDLY NOT PRIMED BEFORE USE. LOT#: 8078465 AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED: NO INSULIN FLOW DURING INJECTION. DOES NOT PRIME BEFORE USE. SHE EXPERIENCED THIS ISSUE WITH 2 BOXES STATED, WASTING A LOT OF PEN NEEDLES".

  Patient problems: No Patient Involvement

  MAUDE report 9110347 ↗
• MalfunctionSep 12, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE TEAR DROP LABEL IS MISSING THUS AFFECTING STERILITY WITH A BD PEN NDL 31G 5MM. THIS OCCURRED ON 5 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TEAR DROP LABEL OF THE PEN NEEDLE IS MISSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9008521 ↗
• MalfunctionJun 19, 2019Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT NEEDLE DID NOT DELIVER MEDICATION AND WAS BENT AFTER INJECTION WITH A BD PEN NDL 31G 5MM. THE CLOG OCCURRED ON 8 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320882, BATCH NO: 8078465. IT WAS REPORTED THAT NEEDLE CLOG DURING INJECTION AND ALSO IT WAS REPORTED THAT NEEDLE WAS BENT AFTER REMOVING FROM THE PEN. ADDITIONAL INFORMATION PROVIDED BY CONSUMER: SPOUSE OF CONSUMER REPORTED NOTHING COMES OUT OF THE PEN NEEDLE DURING THE INJECTION. INSULIN DOESN'T DISPENSE EVEN AFTER SHE PRESSES THE PLUNGER. SAMPLE-DISCARDED. OCCURENCE-8; INCIDENT DATE-UNKNOWN. SHE DOES NOT DO THE PRIMING. SHE DOES THE VISUAL TEST ON THE NEEDLE TO SEE IF ITS STRAIGHT. SHE USES NEW PEN NEEDLE EACH TIME OF HUSBANDS INJECTION. SHE DOES ROTATE THE INJECTION SITE. ITEM# 320882; LOT# 8078465; EXPIRATION DATE-02-28-2023. SHE ALSO REPORTED ABOUT THE BENT PEN NEEDLE AFTER REMOVING IT FROM THE PEN. SAMPLE DISCARDED. ITEM# 320882; LOT-8078465; EXPIRATION DATE-2023-02-28. SAMPLE DISCARDED. OCCURENCE-UNKNOWN; INCIDENT-UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8713832 ↗
• MalfunctionApr 17, 2019Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN PEN NEEDLE JAMMED DURING THE INJECTION AND DURING PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT THE NEEDLE JAMS WHEN DOING INJECTION AND SOMETIMES DURING PRIMING."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8523975 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED THAT HALF A BOX OF BD¿ ULTRA-FINE PEN NEEDLES WERE BROKEN DURING INJECTION OF VICTOZA, AND THERE WAS A NEED TO PRESS HARDER TO INJECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8276529 ↗
• InjuryDec 31, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE¿ MINI PEN NEEDLE THERE WAS AN ISSUE WITH AFTER INJECTION THERE IS RED BRUISING THE SIZE OF A QUARTER, A BROWN SCAR, AND ITCHING IN THE SITE.

  Patient problems: Bruise/Contusion; Itching Sensation; Scarring

  MAUDE report 8206648 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072105. One submission often covers many models, so check the product and lot details in each record.

• Z-1645-2026 · Feb 11, 2026 · Open, Classified
  BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
• Z-0186-2024 · Sep 15, 2023 · Open, Classified
  Alaris PCA Module 8120
• Z-0184-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris PCU REF 8015
• Z-0185-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris Syringe Module, REF 8110
• Z-1192-2023 · Jan 24, 2023 · Open, Classified
  Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255