Recalls distributed in South Dakota – page 2

• Quantum Rehab Product Name: Quantum Outback Model recall
  FDA August 12, 2026 · Pride Mobility Products Corp. · Class II
• Quantum Rehab Product Name: Quantum 4Front 2 Model recall
  FDA August 12, 2026 · Pride Mobility Products Corp. · Class II
• KC Everyday Mac & Cheese, 3lb x 6. Item # 20609055… recall
  FDA August 12, 2026 · Kerry, Inc · Class I
• Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that… recall
  FDA August 5, 2026 · ResMed Ltd. · Class I
• Boston Scientific TheraSphere 360 Y-90 Management Platform… recall
  FDA July 29, 2026 · Boston Scientific Corporation · Class II
• SeaSpine Polyaxial Head recall
  FDA July 29, 2026 · Seaspine Orthopedics Corporation · Class II
• Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS recall
  FDA July 22, 2026 · Orthofix U.S. LLC · Class II
• Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS recall
  FDA July 22, 2026 · Orthofix U.S. LLC · Class II
• Orthofix MINIRAIL, SHORT, LENGTHENER recall
  FDA July 22, 2026 · Orthofix U.S. LLC · Class II
• Orthofix MINIRAIL, STANDARD LENGTHENER Model recall
  FDA July 22, 2026 · Orthofix U.S. LLC · Class II
• da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13… recall
  FDA July 22, 2026 · Intuitive Surgical, Inc. · Class II
• Amy's ORGANIC SOUPS LENTIL LIGHT IN SODIUM NET WT. 14.5 OZ… recall
  FDA July 22, 2026 · Amy's Kitchen Inc. · Class II
• functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT… recall
  FDA July 22, 2026 · Nutricia North America · Class II
• functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT… recall
  FDA July 22, 2026 · Nutricia North America · Class II
• Geneva Product Name: Brachytherapy Applicator Product Description: The… recall
  FDA July 15, 2026 · Elekta, Inc. · Class II
• Brachytherapy Applicator Product Name: Advanced Gynecological Applicator… recall
  FDA July 15, 2026 · Elekta, Inc. · Class II
• Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote… recall
  FDA July 15, 2026 · Elekta, Inc. · Class II
• EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model recall
  FDA July 15, 2026 · Encore Medical, LP · Class II
• EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model recall
  FDA July 15, 2026 · Encore Medical, LP · Class II
• Intracept Access Instruments, Description recall
  FDA July 15, 2026 · Boston Scientific Neuromodulation Corporation · Class II
• GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recall
  FDA July 8, 2026 · W L Gore & Associates, Inc. · Class II
• 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code:… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code:… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code:… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code:… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code:… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code:… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code:… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• Covidien Shiley Disposable Decannulation Plug recall
  FDA July 8, 2026 · Covidien, LP · Class II
• Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton)… recall
  FDA July 8, 2026 · Teleflex LLC · Class II
• IntelliCuff, Portable automatic cuff pressure controller recall
  FDA July 8, 2026 · Hamilton Medical AG · Class II
• Breathing circuit set, coaxial recall
  FDA July 8, 2026 · Hamilton Medical AG · Class I
• Philips Telemetry Monitor 5500 1.4 GHz recall
  FDA July 1, 2026 · Philips North America Llc · Class II
• INZONE DETACHMENT SYSTEM recall
  FDA July 1, 2026 · Stryker Neurovascular · Class II
• Da Vinci ASSY, PSS, SP1098, Part Number: 380601 recall
  FDA July 1, 2026 · Intuitive Surgical, Inc. · Class II
• BD Connecta" BD Luer-Lok" 360 recall
  FDA June 24, 2026 · Bd Switzerland Sarl · Class II
• iLet Bionic Pancreas recall
  FDA June 24, 2026 · Beta Bionics, Inc. · Class II
• STAAR ICL Calculation Software Software Version: Version 8.00 Product… recall
  FDA June 24, 2026 · Staar Surgical AG · Class II
• REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PICC ACCESS TRAY/ASK-04001-CG1 recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: ACCESS TRAY/ASK-04001-MC3 recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PARACENTESIS KIT/ASK-00376-JHH recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU recall
  FDA June 24, 2026 · Arrow International, LLC · Class I