DeRoyal Industries Inc recall records

174 reported ongoing

181 records in this archive. Latest source date May 18, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Mov...

Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. Th...

Class IIReported ongoing

Distribution: U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A

Official source for DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connec...
FDA device enforcement

DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement

The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.

Class IIReported ongoing

Distribution: U.S.: ND, NY, VA, WV, NJ, TN, OK, TN, GA, OH, MN, AZ, WI, IL, MA, MD, MO, AR, MS, NY, MS, SC, HI, AR, UT, HI, O.U.S.: Kuwait

Official source for DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is ...
FDA device enforcement

DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06

DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source ...

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of OH.

Official source for DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
FDA device enforcement

DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit

DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.

Class IIReported ongoing

Distribution: Pennsylvania

Official source for DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
FDA device enforcement

Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF ...

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH...
FDA device enforcement

Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL H...

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGI...
FDA device enforcement

Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, ...

The custom procedure packs contain light handle covers that have been recalled by another firm.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of VA.

Official source for Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hosp...
FDA device enforcement

Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Mem...

The custom procedure packs contain light handle covers that have been recalled by another firm.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of VA.

Official source for Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley...
FDA device enforcement

DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B

The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.

Official source for DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
FDA device enforcement

DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10

DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wri...

Class IIReported terminated

Distribution: US Nationwide distribution in the states of IL, MO.

Official source for DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10

Reasons in these listed records

  • Sterile wound dressing, lacks sterility assurance
  • Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in i...
  • The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.
  • DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active af...

These examples come from this result page and are not a ranking of every recall reason.

Checking DeRoyal Industries Inc

Is there a recall on deroyal industries inc right now?

This archive contains 181 records, including 174 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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