South Carolina recalls

Medtronic received two complaints of loose foreign material inside the DLP One-Piece Pediatric Arterial Cannula (Product Number 77010), a tube used during heart-lung bypass surgery in children. Testing confirmed the material contained trace levels of blood. No injuries have been reported.

Medline kits containing Zimmer Biomet mixing bowls and spatulas have seal defects that could compromise sterility during knee replacement surgery. The issue may require surgeons to obtain replacement equipment during the procedure, but no patient injuries have been reported.

Medline surgical kits containing Zimmer Biomet mixing bowls and spatulas have a seal defect that could compromise sterility. This defect could require surgeons to find an alternative device during a procedure. No injuries have been reported.

Papablic Replacement Brush Heads (Model PAPA317AA) may break during use. The recall affects specific lot numbers: PS2509A01, PS2511A01, and PS2512A01. No injuries have been reported.

Papablic Replacement Brush Heads (Model Papablic18B) with specific lot numbers may break during use. The recall affects about 14,700 packs sold nationwide with lot numbers PS2509A01, PS2511A01, or PS2512A01 (date codes 2509, 2511, 2512).

Orthofix external fixation devices used in orthopedic and trauma surgery have been shipped with incorrect labels. Some M101 models were labeled as M103, M103 models as M101, and M122 models as M111. This labeling error could lead to selection of the wrong device size during surgical procedures.

Some Orthofix Articulated Minirail Fixator external fixation devices have been shipped with incorrect labels. Specifically, M101 units were labeled as M103, M103 units were labeled as M101, and M122 units were labeled as M111. Using the wrong component could affect the stability and effectiveness of orthopedic fixation.

Orthofix Minirail orthopedic external fixation devices were shipped with incorrect model labels. Some M101 devices were labeled as M103, M103 devices were labeled as M101, and M122 devices were labeled as M111. This labeling error could cause confusion during surgical planning and device selection.

GE HealthCare identified that some Optima XR200/220/240amx systems that underwent column replacement may not have had proper safety testing completed. If an internal cable fails, the safety mechanism could malfunction, allowing the X-ray arm to drop unexpectedly during patient exams.

Boston Scientific's Rapid Refill Continuous Injection System contains a recalled syringe component that may loosen or disconnect from the device manifold. This could result in fluid leakage, inability to inject or aspirate properly, or complete separation of the syringe, potentially requiring device replacement and extending the procedure.

In certain conditions, the Plum Solo Precision IV pump (v1.0.3) may not properly track the volume of fluid being delivered and could administer up to twice the intended amount of medication or fluid. This affects specific serial numbers of the pump.

Certain ICU Medical Plum Duo infusion pumps may fail to track the amount of fluid delivered on the screen display. In rare cases, this could cause the pump to deliver up to twice the intended volume of medication or fluid. This affects specific serial numbers of two item numbers (400020401 and 400020403) running software version 1.2.3.

Arm drapes used with Intuitive Surgical's da Vinci SP robotic surgical system may detach from the instrument arm due to a defect in the drape rings at the top of the product. If a drape detaches during surgery, it can expose part of the instrument arm and may delay the procedure or require switching to an alternative surgical approach.

Olympus has recalled the Glass Body for the 194 Ellik Evacuator (Model 190A) because some sterilization instructions in the user manual may not reliably make the device sterile. The affected sterilization parameters should no longer be used.

Olympus has recalled the Ellik Evacuator (Model 194), a medical device used during urological procedures. Some sterilization methods described in the device instructions may not reliably sterilize the device, creating a potential infection risk.

Olympus has recalled the Toomey Evacuator 50cc with Adaptor (Model 188A) because some sterilization instructions in the product manual may not reliably make the device fully sterile. Affected units were distributed worldwide, including across the US, Canada, Japan, Europe, and Latin America.

Olympus has recalled the Toomey Evacuator 30cc with Adaptor (Model 188) because some of the sterilization instructions in the device manual may not reliably make the device sterile. The affected instructions should no longer be used.

Argon Medical Devices is recalling bone marrow tray kits (models CB0033TL and CB0355TLA) that contain lidocaine injections. The lidocaine ampules in these kits did not meet sterility standards required for safe use. The kits were distributed nationwide and internationally.

Argon Medical Devices is recalling certain Arterial Line Kits (model 20ga x 6, REF: 400115A) that contain Lidocaine HCL Injection. These kits failed sterility testing and do not meet safety release criteria. The affected kits have specific lot numbers with expiration dates in July 2027.

Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits that contain Lidocaine HCL Injection ampules. These kits failed to meet sterility standards during quality testing. The affected kits were distributed nationwide and internationally.

Argon Medical Devices is recalling General Biopsy Trays (REF: GUTS1000) that contain Lidocaine HCL Injection ampules. The lidocaine ampules in these kits did not meet sterility release criteria, meaning they may not be safe for use. Approximately 1,800 kits were distributed nationwide and to Trinidad and Tobago.

Argon Medical Devices is recalling One-Piece Introducer Trays (REF 497455 and 497434) that contain Lidocaine HCL Injection ampules. The Lidocaine ampules in these kits did not meet sterility release criteria, meaning they were not verified as free from contamination before distribution.

Argon Medical Devices is recalling certain transvenous pacing electrode trays (model 008416A and 008566A) because they contain lidocaine ampules that did not meet sterility standards. The affected kits were distributed nationwide and internationally. No injuries have been reported.

Abiomed heart pump introducer sheaths in the Intro Kit may leak fluid from under the sheath cap or along the hub score lines. The manufacturing defect is not visible to users. All current batches of the kit worldwide are affected.

Abiomed has recalled the Impella CP heart pump due to a potential for fluid leakage from the introducer sheath (a tube inserted during the procedure). The leakage can occur under the sheath cap or along connection points, and these defects cannot be seen by the user. All current batches of the pump set are affected worldwide.

Abiomed has recalled its Impella CP Smart Assist Set heart pump due to a potential leak in the introducer sheath (a thin tube used during insertion). The leak can occur under the sheath cap or along seam lines in certain models, but the defect is not visible to the user. All current batches worldwide are affected.

Abiomed has recalled the Impella CP heart pump set due to a manufacturing defect in the introducer sheath that can cause leakage. The leakage can occur under the sheath cap or along hub score lines in the 14Fr and 23Fr introducers included with every pump set, and the defect is not visible to users.

Abiomed has recalled certain Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a manufacturing defect in the introducer sheaths. The 14Fr and 23Fr introducers included in these pump sets may leak fluid from under the sheath cap or along hub seams, and the leakage cannot be seen by the user before or during use.

The Abiomed Impella 5.5 Smart Assist Set heart pump contains an introducer sheath that may leak under the cap or along hub seams. This manufacturing defect is not visible to the user but is present in all affected pump sets. The issue affects 383 units distributed worldwide.

Abiomed has recalled certain Introducer Kit 23 Fr units (Pump Set Code 1000441) due to a potential for sheath leakage from under the sheath cap and along hub score lines. This manufacturing issue cannot be seen by the user and affects introducers included in every pump set.