Alaris 9601 (UDI 10885403960109)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10885403960109), received between Apr 4, 2018 and Oct 10, 2023 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (11 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED WHILE USING BD¿ HOME SHARPS CONTAINER, 1.4 QUART THE SHARPS PIERCED THE WALL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED CALLER THOUGHT HE COULD INSERT A EPPE PEN INTO THE SHARPS CONTAINER. PLUS REMOVE THE NEEDLE FROM THE EPPE PEN ACCORDING TO THE DIRECTIONS ON THE BOX AS HE READ IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909498 ↗
• MalfunctionAug 30, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE BD¿ HOME SHARPS CONTAINER, 1.4 QUART LID WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HARD TIME CLOSING THE LID TO CONTAINER. THIS CALLER HAS NEUROPATHY AND NOT A LOT OF STRENGTH. THIS CONTAINER DOES NOT HAVE SHARPS IN IT AS OF YET. INFORMED CALLER TO PLACE LID ONTO CONTAINER ONLY WHEN FULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17654752 ↗
• MalfunctionNov 23, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE BD¿ HOME SHARPS CONTAINER LID LATCH WAS DAMAGED AND WOULD NOT LOCK INTO PLACE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FINDING THE FULL OF LANCETS CONTAINER WILL NOT ALLOW THE LID TO LOCK ONTO IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866427 ↗
• MalfunctionMar 8, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE PEN NEEDLE WAS DIFFICULT TO DETACH FROM THE INSULIN PEN INTO THE BD¿ HOME SHARPS CONTAINER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED SHE IS UNABLE TO REMOVE THE PEN NEEDLE FROM HER INSULIN PEN INTO THE BD HOME SHARPS CONTAINER. STATED SHE CAN REMOVE THE PEN NEEDLE EASILY WITH HER FINGERS BUT IT WILL NOT GO INTO THE SHARPS CONTAINER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441185 ↗
• MalfunctionMay 26, 2020Defective Device; Difficult to Open or Close; Defective Device; Difficult to Open or Close

  IT WAS REPORTED THAT SHARPS CONTAINER 1.4 QT HOME LID BROKE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 323487 BATCH NO. UNKNOWN. IT WAS REPORTED THAT HUSBAND WENT TO CLOSE AND LOCK SHARPS CONTAINER LID AND HE ACCIDENTLY BROKE IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10090033 ↗
• MalfunctionMay 13, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT SHARPS CONTAINER 1.4 QT HOME LID WAS DIFFICULT TO OPERATE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CONSUMER PLACED LID ONTO THE CONTAINER BEFORE BEING FULL, ASKING HOW TO REMOVE LID.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10053503 ↗
• MalfunctionMar 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A NOVO-PLUS SAFETY SYRINGE WOULD NOT FIT INTO THE BD¿ HOME SHARPS CONTAINER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED -WOULD NOT ACCEPT A NOVO PLUS SAFETY SYRINGE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9794883 ↗
• MalfunctionJan 27, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD HOME SHARPS CONTAINER WOULD NOT ALLOW THE PEN NEEDLES TO FIT INSIDE THE CONTAINER. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 323487 BATCH NO.: UNKNOWN. IT WAS REPORTED THE PEN NEEDLE THE CONSUMER USES FOR HER HEADACHES WILL NOT FIT INTO THE CONTAINER. ADVISED THIS CONSUMER THEY WOULD NOT BE COMPATIBLE, ONLY INSULIN SYRINGES AND PEN NEEDLES. SHE MENTIONED A FEW TIMES IT SAYS PENS CAN BE DISPOSE OF ON THE BOX, BUT SAID HER PEN WAS TOO WIDE AT ONE END AND WOULD NOT FIT INSIDE HOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9635053 ↗
• MalfunctionJan 17, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD HOME SHARPS CONTAINER WOULD NOT ALLOW THE SYRINGES TO FIT INSIDE THE CONTAINER. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 323487 BATCH NO. UNKNOWN. IT WAS REPORTED THAT SYRINGES ARE UNABLE TO BE DISPOSED IN SHARPS CONTAINER. VERBATIM: FROM PHONE CALL ON 2020-01-02 16:15:55: RETURNED CALL, PARENT STATED HER DAUGHTER USES THE PREFILLED SYRINGES AND SHE IS UNABLE TO DISPOSE IT IN THE SHARP CONTAINER. EXPLAINED THE PARENT THIS CONTAINER IS NOT COMPATIBLE FOR THE PREFILLED SYRINGES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9603724 ↗
• MalfunctionJan 2, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD HOME SHARPS CONTAINER NEEDLE WILL NOT FIT INTO THE CONTAINER. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 323487 BATCH NO. 9213001. IT WAS REPORTED THAT SHE CAN NOT DISPOSE THE NEEDLE FROM HER INSULIN PUMP IN CONTAINER. HAS TO USE SCREWDRIVER TO PUSH INSIDE. ISSUE: CONSUMER REPORTED SHE CANNOT DISPOSE THE NEEDLE FROM HER INSULIN PUMP IN THIS CONTAINER, SHE HAD TO USE SCREWDRIVER TO PUSH. HER HUSBAND ORDERS HER CONTAINERS, SHE IS NOT SURE WHICH SIZE HE HAD ORDERED IN THE PAST. EXPLAINED THIS CONTAINER MAY NOT BE COMPATIBLE FOR NEEDLES TO DISPOSE. EXPLAINED TO CHECK WITH THE SUPPLIERS TO SEND THE RIGHT SIZE SHE WAS GETTING IN THE PAST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9538981 ↗
• MalfunctionOct 23, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT BD HOME SHARPS CONTAINER IS NOT WORKING. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 323487 BATCH NO. UNKNOWN. IT WAS REPORTED THAT HOME SHARPS CONTAINER IS NOT WORKING. CONSUMER REPORTED DIFFICULT TIME CLOSING LID AND ONCE IT WAS CLOSED, COULD NO REOPEN THE LID. RETURNED CALL, CONSUMER STATED SHE BOUGHT THE SMALL SHARP CONTAINER AND SHE WANTED TO CLOSE IT SINCE SHE DID NOT WANT TO LEAVE IT OPEN BECAUSE OF THE NEEDLES INSIDE IT. SHE TOOK IT TO THE PHARMACY TO COVER THE LID, THEY WERE NOT ABLE TO DO IT, AND FINALLY CLOSED THAT LID, THEY COULD NOT OPEN THE LID. SHE HAS USED THE DIFFERENT COMPANIES LARGER CONTAINER WHERE THEY CAN CLOSE IT AND OPEN IT EASILY. THIS HAPPENED LAST WEEK. DURING THE PROCESS OF OPENING THE LID, SHE BROKE HER FINGER NAILS, DID NOT SEEK MEDICAL ATTENTION, NO OTHER INJURIES. EXPLAINED CONSUMER LID IS TO CLOSE IT ONCE ITS REACHES THE LINE AND AFTER SHE CLOSES THE LID IT GETS PERMANENTLY LOCKED. EXPLAINED ABOUT THE FREE BRACKET, OFFERED TO SEND THE SHARP CONTAINER AND BRACKET, CONSUMER REFUSED. CONSUMER LEFT VOICEMAIL REPORTING HOME SHARPS CONTAINER NOT WORKING.

  Patient problems: No Code Available

  MAUDE report 9226935 ↗
• MalfunctionOct 8, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE LID ON THE BD¿ HOME SHARPS CONTAINER "POPPED" OPEN AFTER DISPOSING LANCETS AND TEST STRIPS IN IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLACES HER LANCETS AND TEST STRIPS WITHIN CONTAINER AND LIGHTLY PLACES LID ON CONTAINER WITH EACH USE. THEN PLACES LID FULLY ON CONTAINER WHEN DISPOSING. FEELS THE LID IS NOT STURDY OR SECURE FOR DISPOSAL , IT POPS OPEN."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9166294 ↗
• MalfunctionOct 1, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE LID WAS FOUND CLOSED ON THE BD¿ HOME SHARPS CONTAINER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED HIS SHARPS CONTAINER LID WAS CLOSED RIGHT OUT OF THE BOX."

  Patient problems: No Patient Involvement

  MAUDE report 9142342 ↗
• MalfunctionSep 30, 2019Difficult to Open or Close; Difficult to Open or Close

  MATERIAL NO. 323487. BATCH NO. UNKNOWN. IT WAS REPORTED THAT BEFORE USE OF THE BD¿ HOME SHARPS CONTAINER THE LID WAS HARD TO GET OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LID WAS HARD TO GET OFF AND SHE THINKS SHE MAY HAVE CLOSED IT IN ERROR BEFORE SHE USED IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9136686 ↗
• MalfunctionSep 26, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE BD¿ HOME SHARPS CONTAINER WAS FOUND CLOSED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER CALLED TO REPORT HER SHARP CONTAINER WAS CLOSED WHEN SHE RECEIVED IT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9125919 ↗
• MalfunctionSep 26, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE CONSUMER WAS NOT ABLE TO OPEN LID AND INSTRUCTIONS DID NOT SAY IT WAS UNABLE TO BE OPENED ONCE CLOSED WITH A BD HOME SHARPS CONTAINER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CONSUMER CLOSED BRAND NEW CONTAINER IN ERROR. STATED THERE ARE NO INSTRUCTIONS STATING YOU CAN NOT OPEN ONCE IT IS CLOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9125384 ↗
• MalfunctionSep 5, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT LID WAS MISSING WITH A BD SHARPS CONTAINER 1.4 QT HOME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT HOME SHARPS CONTAINERS WERE MISSING LIDS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8965522 ↗
• MalfunctionAug 29, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE NEEDLE WOULDN'T FIT INTO THE BD¿ HOME SHARPS CONTAINER HOLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PEN NEEDLE TRU PLUS, 28G 1/2" WILL NOT FIT INTO THE HOLE IN CONTAINER HAS USED THESE TWO ITEMS TOGETHER BEFORE IN PAST."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8945275 ↗
• MalfunctionAug 22, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD¿ HOME SHARPS CONTAINER WILL NOT REMOVE THE NEEDLE FROM THE PEN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 323487. BATCH NO.: UNKNOWN. IT WAS REPORTED BY THE CONSUMER THAT THE CONTAINER WOULD NOT REMOVE THE NEEDLE FROM THE BYDUREON PEN. VERBATIM: CONSUMER REPORTED HE COULD NOT UNSCREW THE NEEDLE FROM HIS BYDUREON PEN. INCIDENT DATE (B)(6) 2019. OCCURENCE-1. EXPLAINED CONSUMER THE SHARP CONTAINER WILL NOT REMOVE THE NEEDLE FROM THAT PEN. HE NEEDS TO DISPOSE IT WITHOUT REMOVING THE NEEDLED. ADVISED HIM TO CALL THE MANUFACTURERS TO PROVIDE HIM THE INFORMATION ON WHICH SHARPS CONTAINER HE CAN USE TO DISPOSE THAT. ALSO PROVIDED HEALTH DEPARTMENT NUMBER FOR CONSUMER TO CONTACT REGARDING DISPOSAL INFORMATION. ITEM# 323487. LOT# UNKNOWN. NO FURTHER INFORMATION AVAILABLE. NO CONTACT INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8921230 ↗
• MalfunctionMay 28, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT PRODUCT IS DAMAGED WITH A BD SHARPS¿ CONTAINER 1.4 QT HOME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 323487; BATCH NO: 8099001. VERBATIM: IT WAS REPORTED THAT THE CONSUMER FOUND A PEN NEEDLE OPENING TABS ITEM: 323487; LOT # 8099001 FOUND THE PEN NEEDLE OPENING "TABS" ON THE OPENING ARE BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8647326 ↗
• MalfunctionMay 16, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE HOME SHARPS CONTAINER WAS UNABLE TO FIT A PEN NEEDLE WITH A COVER INSIDE IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 323487 BATCH NO. UNKNOWN VERBATIM: CONSUMER REPORTED HE HAD DIFFICULTY DETACHING THE PEN NEEDLE IN THE SHARP CONTAINER. INSTRUCTED HOW TO REMOVE THE PEN NEEDLE FROM THE CONTAINER. HE WAS UNABLE TO DETACH THE PEN NEEDLE. ASSISTED CONSUMER TO HELP REMOVING THE PEN NEEDLE FROM THE CAP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8617443 ↗
• MalfunctionApr 23, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THERE WAS DIFFICULTY OPENING LID WITH A BD SHARPS CONTAINER¿ 1.4 QT HOME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THE SHARP CONTAINER HAD ITS LID CLOSED AND CANNOT OPEN IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8541613 ↗
• MalfunctionMar 19, 2019Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT BD¿ SHARPS COLLECTOR HAD NO LID. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO: 323487 BATCH NO: UNKNOWN. IT WAS REPORTED: THAT THE HOME SHARPS CONTAINER JUST PURCHASED HAS NO LID VERBATIM: 323487 THIS HOME SHARPS CONTAINER JUST PURCHASED HAS NO LID. SENDING NEW CONTAINER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8433254 ↗
• MalfunctionFeb 22, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT BD¿ SHARPS COLLECTOR WOULD NOT ALLOW THE PEN NEEDLE TO FIT INTO THE HOLE OF THE SHARPS CONTAINER WITH THE OUTER COVER ON. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8363937 ↗
• MalfunctionDec 12, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD¿ SHARPS COLLECTOR HAD INCORRECT LABEL INFORMATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155261 ↗

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-0184-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris PCU REF 8015
• Z-0186-2024 · Sep 15, 2023 · Open, Classified
  Alaris PCA Module 8120
• 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