Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

• 2026-08-03Open, ClassifiedUnder Investigation by firm

  STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600

  There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

• 2026-08-03Open, ClassifiedUnder Investigation by firm

  STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620

  There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

• 2026-08-03Open, ClassifiedUnder Investigation by firm

  STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640

  There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

• 2026-01-28Open, ClassifiedError in labeling

  Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUSOnly - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUSOnly - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL

  The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.

• 2025-07-23Open, ClassifiedUnder Investigation by firm

  Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip

  Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

• 2024-12-31Open, ClassifiedProcess control

  SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.

  Incomplete or partial pouch seals, which may result in a breach in the sterility.

• 2024-01-18Open, ClassifiedProcess control

  CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510

  The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

• 2024-01-18Open, ClassifiedProcess control

  Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516

  The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

• 2024-01-18Open, ClassifiedProcess control

  Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517

  The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

• 2013-12-06TerminatedProcess control

  Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.

  Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating.