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All product recalls affecting South Dakota.
Includes nationwide recalls (tagged “Nationwide”) and recalls with South Dakota in the distribution area.
The kits contain certain lots of cannula products where the catheter may not retain its shape.
The CX Combi Boilers are single, compact residential gas boilers that provide both central heating and hot water on demand. The CX Combi Boilers are rectangular metal boxes with a control panel on the front and a red IBC label in the top left corner. Only models CX-199 and CX-150 with certain serial numbers are included in the recall. The CX-199 or CX-150 model number is located on the upper left corner of the touch screen on the front of the unit. The model and serial numbers are found on the rating plate located on the inside of the unit in the upper left corner and the serial number is outlined in rectangular boxes. Only CX Combi Boilers with the following model and serial numbers are included in the recall: CX Series boilers manufactured between April 2023 and April 2024 Model Serial Number Start Serial Number End 010-130A1 / CX 199-NG ICGFSW1-0199-230400064 ICGFSW1-0199-240300821 010-131A1 / CX 199-LP ICGFSW1-0199-230700336 ICGFSW1-0199-240400827 010-132A1 / CX 150-NG ICGFSW1-0150-230500056 ICGFSW1-0150-240400582 010-133A1 / CX 150-LP ICGFSW1-0150-230700192 ICGFSW1-0150-240400583 CX Series boilers manufactured between June 2024 and April 2025 Model Serial Number Start Serial Number End 010-130A1 / CX 199-NG I262400165 I162500429 010-131A1 / CX 199-LP I262400137 I162500430 010-132A1 / CX 150-NG I292400198 I102500001 010-133A1 / CX 150-LP I442400415 I022500103
Labeling includes shelf life that has not been validated.
Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
Labeling includes shelf life that has not been validated.
Labeling includes shelf life that has not been validated.
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.
Labeling includes shelf life that has not been validated.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Aluminum Trailer Company (ATC) is recalling certain 2023 PL500, 2023-2024 PL700, 2023-2025 RM500, RM900, ST450, 2024-2025 PL550, PL750, 2024 PR300, 2025 RM450, RM550, and RM800. A software error may cause the radio and speakers to overheat.
General Motors, LLC (GM) is recalling certain 2023–2026 Chevrolet Corvette vehicles equipped with a left-side radiator/fan combination. Excess fuel may spill into the vehicle fuel-filler pocket during refueling and leak onto an ignition source.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).