BD PhaSealRecalls & reported problems across all models
BD Switzerland Sàrl · 23 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one BD PhaSeal model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 992
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 2
We found 23 models of BD PhaSeal by BD Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 992 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2017 and Sep 29, 2026 — classified as 11 injuries, 981 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (386 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
BD PhaSeal recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 16, 2025Open, Classified
Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.
Z-2453-2025 · Root cause: Error in labeling · names 22 of these models · Recall details · FDA record ↗
- Jul 18, 2022Open, Classified
Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.
Z-1555-2022 · Root cause: Employee error · Recall details · FDA record ↗
Most reported BD PhaSeal problems
Device problems
- Leak/Splash386
- Device Contamination with Chemical or Other Material127
- Break69
- Contamination62
- Fluid/Blood Leak51
- Disconnection47
- Difficult or Delayed Activation38
- Infusion or Flow Problem34
Patient problems
- No Clinical Signs, Symptoms or Conditions502
- No Known Impact Or Consequence To Patient298
- No Consequences Or Impact To Patient90
- No Patient Involvement32
- Chemical Exposure25
- Insufficient Information24
- No Information21
- Needle Stick/Puncture5
BD PhaSeal models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD PhaSeal 515003Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall183 reports
- BD PhaSeal 515056Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall159 reports
- BD PhaSeal 515005Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall128 reports
- BD PhaSeal 515105Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall71 reports
- BD PhaSeal 515117Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall71 reports
- BD PhaSeal 515304Closed antineoplastic and hazardous drug reconstitution and transfer system2 recalls16 reports
- BD PhaSeal 515106Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall64 reports
- BD PhaSeal 515306Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall54 reports
- BD PhaSeal 515200Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall37 reports
- BD PhaSeal 515102Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall35 reports
- BD PhaSeal 515004Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall34 reports
- BD PhaSeal 515107Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall33 reports
- BD PhaSeal 515100Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall25 reports
- BD PhaSeal 515202Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall20 reports
- BD PhaSeal 515065Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall12 reports
- BD PhaSeal 515104Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall4 reports
- BD PhaSeal 515001Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall2 reports
- BD PhaSeal 515305Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall2 reports
- BD PhaSeal 515103Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall1 report
- BD PhaSeal 515307Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall1 report
- BD PhaSeal 515404Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall1 report
- BD PhaSeal 515406Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall0 reports
- BD PhaSeal 515302Closed antineoplastic and hazardous drug reconstitution and transfer system39 reports
Recent BD PhaSeal adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938987 ↗MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831238 ↗MalfunctionSep 18, 2026Leak/Splash; Use of Device Problem
No additional information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830718 ↗MalfunctionSep 16, 2026Disconnection
Patient problems: Chemical Exposure
MAUDE report 50796944 ↗MalfunctionSep 16, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787127 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724560 ↗MalfunctionSep 9, 2026Disconnection; Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691136 ↗MalfunctionAug 25, 2026Infusion or Flow Problem
The following information was provided by the initial reporter:Material # Unknown. Batch # Unknown.It was reported by customer that "Kink in line above the filter, one way valve on the drip chamber back flowed backwards down to the filter when connected via optima pieces, Does not allow flow of the line as they do circle priming of the sets".Verbatim:10015861A,20350E, plus optima piece.Kink in line above the filter. one way valve on the drip chamber back flowed backwards down to the filter when connected via optima pieces in a circle prime fashion when the valve on the drip chamber should be one way only up into the bag.Multiple overall complaints of kinking from this facility. Does not allow flow of the line as they do circle priming of the sets. They are having to discard the set in most cases and grab new that are not kinked.No patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50429194 ↗MalfunctionAug 16, 2026Disconnection
The following information was provided by the initial reporter:Material #:515056 Batch#: Unknown.It was reported by a customer that they experienced 22 disconnections of the phaseal optima N40 O locking injector to the alaris tubing set spin collars. Verbatim:has experienced 22 disconnects of the Phaseal Optima N40 O locking injector to the Alaris tubing set spin collars. These have led to delays in customer care and spills. Despite training and resources, this has been an ongoing challenge at.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50267868 ↗MalfunctionAug 16, 2026Disconnection
The following information was provided by the initial reporter:Material # :515056 Batch#: Unknown.It was reported by a customer that they experienced 22 disconnections of the phaseal optima N40-O locking injector to the alaris tubing set spin collars. Verbatim:has experienced 22 disconnects of the Phaseal Optima N40 O locking injector to the Alaris tubing set spin collars. These have led to delays in customer care and spills. Despite training and resources, this has been an ongoing challenge at.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263795 ↗MalfunctionAug 4, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131802 ↗MalfunctionJul 31, 2026Contamination
No additional information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50101617 ↗MalfunctionApr 3, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783120 ↗MalfunctionFeb 20, 2026Leak/Splash
IT WAS REPORTED THAT THE BD INJECTOR LOCKING N40-O HAD LEAKAGE THROUGH THE MEMBRANE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 515056 BATCH # UNKNOWN. VERBATIM: 2/1 DOSE OF METHOTREXATE HAD LEAKED OUT THE END OF THE PHASEAL (WHICH SHOULD NOT BE ABLE TO HAPPEN--IT IS SUPPOSED TO BE A CLOSED SYSTEM AND WAS NOT ATTACHED TO THE OTHER PART OF THE PHASEAL WHICH ALLOWS FLOW). THERE WAS SUPPOSED TO BE SOMETHING LIKE 0.32ML IN THE SYRINGE BUT THERE WAS ONLY 0.3 AND WE COULD SEE THE YELLOW CHEMO UNDER THE CLEAR CAP OF THE PHASEAL. CHEMO PHARMACY THANKFULLY MADE US A NEW DOSE AND WE TOOK A PICTURE OF THE LEAKED DOSE HAZARDOUS DRUG EXPOSURE, DELAY IN CARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401043 ↗MalfunctionFeb 4, 2026Leak/Splash
IT WAS REPORTED THAT THE BD INJECTOR LOCKING N40-O HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #515056; LOT #UNKNOWN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. LEAKING FROM AROUND THE RING. I WAS ABLE TO SPEAK TO THE TWO RNS WHO WERE PRESENT. THEY STATED THAT IT WAS LEAKING FROM AROUND THE RING/SEAL OF THE INJECTOR THAT WAS ON THE IV LINE. SO THAT WOULD HAVE BEEN THE PRIMARY LINE THAT THE RNS PLACE THE PHASEAL, BUT THEY WERE ADAMANT THAT IT WAS NOT LEAKING FROM AROUND THE SCREW CONNECTION, THAT IT WAS LEAKING FROM THE RING AROUND THE EDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24264178 ↗
Other BD Switzerland Sàrl products
- Alaris, SmartSite160 models · 10,227 reports · 8 recalls
- Alaris85 models · 2,797 reports · 10 recalls
- MaxZero47 models · 2,377 reports
- MaxGuard49 models · 780 reports · 11 recalls
- MaxPlus18 models · 762 reports · 2 recalls
- BD SmartSite29 models · 568 reports · 4 recalls
- Alaris, SmartSite, Texium12 models · 291 reports · 5 recalls
- BD PhaSeal Optima11 models · 474 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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