BD PhaSeal OptimaRecalls & reported problems across all models

We found 11 models of BD PhaSeal Optima by BD Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 474 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2018 and Sep 30, 2026 — classified as 1 injury, 473 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (242 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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

BD PhaSeal Optima 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.

1. Jun 16, 2025Class IIOpen, 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 9 of these models · Recall details · FDA record ↗

Most reported BD PhaSeal Optima problems

BD PhaSeal Optima models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD PhaSeal Optima 515070

  Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall154 reports
• BD PhaSeal Optima 515052

  Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall114 reports
• BD PhaSeal Optima 515064

  Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall73 reports
• BD PhaSeal Optima 515078

  Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall41 reports
• BD PhaSeal Optima 515060

  Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall24 reports
• BD PhaSeal™ Optima 515057

  Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall21 reports
• BD PhaSeal Optima 515053

  Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall15 reports
• BD PhaSeal Optima 515079

  Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall6 reports
• BD PhaSeal Optima 515062

  Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• BD PhaSeal Optima 515628

  Closed antineoplastic and hazardous drug reconstitution and transfer system
  13 reports
• BD PhaSeal Optima 515629

  Closed antineoplastic and hazardous drug reconstitution and transfer system
  13 reports

Recent BD PhaSeal Optima adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Disconnection

  The following information was provided by the intiial reporter:It was reported that the connection between the injector and the spike port came loose. User reconnected it and continued using the unit as is.Additional Information was received on 15 Sep 2026:Additional information: The information acquisition date was entered incorrectly; the correct date of obtaining information is 9 14. The event occurrence date is 9 8.Follow up performed to verify:What lot was used in this event?Is the facility new to using OptimaHas education been provided on connection techniques.Rep mentioned that:UnknownImplementation began at the end of August. It hasn¿t even been a month yet.A training session has already been held.Additional information provided:A leak has been confirmed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946161 ↗
• MalfunctionSep 28, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923622 ↗
• MalfunctionSep 28, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921295 ↗
• MalfunctionSep 25, 2026Connection Problem

  The following information was provided by the initial reporter:It was reported that anticancer drugs were administered via a C35-0 attached to a Safe T cannula, which was selected for compatibility with the Safe T port. Approximately 30 minutes after the start of administration, the patient exhibited abnormal symptoms. Upon investigation, it was determined that air was entering through the connection point and had entered the patient¿s bloodstream. Although appropriate measures prevented a serious outcome, this was an event that could have led to a life-threatening risk. The C35-0 attached to the Safe-T cannula was connected at an angle. While an installation error is highly likely, the possibility of a defect in the C35-0 itself cannot be ruled out, so we would like this to be verified.Additional information received on 25 Sep 2026Sales Rep mentioned that:It is unclear whether a standalone Safe T-port is being connected to another manufacturer¿s IV set or whether an integrated IV set is being used.It¿s possible that the connection was made at an angle. This appears to be primarily a manual error, such as a misalignment during assembly.I didn't check myself, but it seems a nurse wh

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896547 ↗
• MalfunctionSep 24, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892039 ↗
• MalfunctionSep 23, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876323 ↗
• MalfunctionSep 22, 2026Disconnection; Leak/Splash

  No additional information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862364 ↗
• MalfunctionSep 22, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860028 ↗
• MalfunctionSep 21, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849046 ↗
• MalfunctionSep 18, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831240 ↗
• MalfunctionSep 18, 2026Infusion or Flow Problem

  The following information was provided by the initial reporter:According to the customer report, an incident occurred where air entered in the IV line during chemotherapy use. The product was recalled.Since air was detected in the IV line during administration, the IV connection line was exchanged. (Small container)Air entered the IV line again during administration using the new IV connection line.Although we reported the possibility that air had entered from the JMS spike with an air vent, we were asked to investigate, so we recalled the product.Contaminated with It is the route through which the anticancer drug is administered.Additional information received on 07 Sep 2026.Thank you for contacting us.Did this occur in the primary line or the secondary line? It occurred in the primary line.Did this occur while an infusion pump was in use? It likely occurred while the pump was in use.Is the IV administration set manufactured by BD? It is manufactured by JMS.Was the IV administration set vented? Unknown.If it was vented, was the vent inlet closed? Was the IV administration set primed before the infusion started?Yes, it was primed.How much time had passed since the infusion started

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828908 ↗
• MalfunctionSep 17, 2026Leak/Splash

  The following information was provided by the initial reporter:Customer advised that there was a leak of Azacitidine when being delivered via subcutaneous injection from phaseal optima to needle connection. advised that they put needle onto the connector then into the injector as recommended.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804191 ↗
• MalfunctionSep 17, 2026Leak/Splash

  The following information was provided by the initial reporter:Customer advised that there was a leak of Azacitdine when being delivered via subcutaneous injection from phaseal optima to needle connection.advised that they put connector into injector then added needle to connector. Provided education of the order in which it needs to be connected- needle into connector then connector into injectorAdditional information:The leak occurred after assembling and when the therapy was being administered.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802865 ↗
• MalfunctionSep 17, 2026Break

  The following information was provided by the initial reporter:It was reported that after infusing normal saline into the Abraxane vial, user attempted to collect the solution by connecting a syringe with an injector to the protector. However, the threaded connection between the injector and the syringe broke, so they stopped using it and used a different product instead.Additional information provided:I understand that the damage occurred during the collection process, so I believe that some of the information leaks out.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801727 ↗
• MalfunctionSep 11, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744626 ↗

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