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General Hospital devices
268 product codes reviewed by the General Hospital panel. 15,652 510(k) clearances and 6,297 recalls in the FDA data, 69% of those recalls name a 510(k).
151510(k)s in 12 months
328recalls in 12 months
4,368recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 1,090 | 110 |
| FRN | Pump, Infusion | 724 | 24 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 394 | 6 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 332 | 9 |
| FMI | Needle, Hypodermic, Single Lumen | 311 | 3 |
| FMF | Syringe, Piston | 305 | 4 |
| FMG | Stopcock, I.V. Set | 207 | 19 |
| LRS | I.V. Start Kit | 166 | 15 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 155 | 1 |
| FSA | Lift, Patient, Non-Ac-Powered | 143 | 10 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 141 | 1 |
| LZG | Pump, Infusion, Insulin | 126 | 3 |
| MEB | Pump, Infusion, Elastomeric | 109 | 0 |
| MCY | Wound Dressing Kit | 101 | 9 |
| FPO | Stretcher, Wheeled | 77 | 2 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | 2 | 6 | 110 |
| FRN | Pump, Infusion | 2 | 2 | 24 |
| LZA | Polymer Patient Examination Glove | 1 | 17 | 3 |
| FMG | Stopcock, I.V. Set | 2 | 0 | 19 |
| FMF | Syringe, Piston | 2 | 13 | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 13 | 3 |
| LRS | I.V. Start Kit | 2 | 0 | 15 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 8 | 6 |
| OXQ | Dressing Change Tray | 1 | 0 | 14 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 4 | 9 |
| FSA | Lift, Patient, Non-Ac-Powered | 1 | 0 | 10 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 10 | 0 |
| FRC | Indicator, Biological Sterilization Process | 2 | 1 | 8 |
| KGX | Tape And Bandage, Adhesive | 1 | 0 | 9 |
| MCY | Wound Dressing Kit | 2 | 0 | 9 |
| LLI | Bed, Therapeutic, Ac-Powered, Adjustable Home-Use | 2 | 0 | 7 |
| FLE | Sterilizer, Steam | 2 | 5 | 1 |
| FMZ | Incubator, Neonatal | 2 | 2 | 3 |
| FRG | Wrap, Sterilization | 2 | 5 | 0 |
| LZG | Pump, Infusion, Insulin | 2 | 2 | 3 |
| PND | Midline Catheter | 2 | 1 | 4 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | 0 | 4 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 2 | 4 | 0 |
| JOL | Catheter And Tip, Suction | 2 | 0 | 4 |
| LGZ | Warmer, Thermal, Infusion Fluid | 2 | 3 | 1 |
| LRJ | Disinfectant, Medical Devices | 1 | 0 | 4 |
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 2 | 1 | 3 |
| OWL | Peripheral Catheter Insertion Kit | 2 | 0 | 4 |
| PAD | Chest Drainage Kit | 2 | 0 | 4 |
| PXI | Thoracentesis Tray | 2 | 0 | 4 |
| FLL | Continuous Measurement Thermometer | 2 | 2 | 1 |
| KPE | Container, I.V. | 2 | 3 | 0 |
| LHI | Set, I.V. Fluid Transfer | 2 | 2 | 1 |
| MMK | Container, Sharps | 2 | 3 | 0 |
| PHC | Infusion Safety Management Software | 2 | 1 | 2 |
| QTG | Infant Supine Sleep System | 2 | 0 | 3 |
| SDC | Qualitative Cleaning Process Protein Indicator | 2 | 1 | 2 |
| FMT | Warmer, Infant Radiant | 2 | 0 | 2 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 2 | 0 | 2 |
| FPO | Stretcher, Wheeled | 2 | 0 | 2 |
| FQH | Lavage, Jet | 2 | 2 | 0 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 | 1 | 1 |
| LZC | Medical Glove, Specialty | 1 | 1 | 1 |
| MEC | Disinfector, Medical Devices | 2 | 0 | 2 |
| MED | Sterilant, Medical Devices | 2 | 2 | 0 |
| MEG | Syringe, Antistick | 2 | 2 | 0 |
| MLR | Sterilizer, Chemical | 2 | 2 | 0 |
| NEP | System/Device, Pharmacy Compounding | 2 | 0 | 2 |
| NGT | Saline, Vascular Access Flush | 2 | 1 | 1 |
| OKE | Port Introducer Kit | 2 | 0 | 2 |
| PTI | Non-Coring (Huber) Needle | 2 | 2 | 0 |
| QBP | Cap, Device Disinfectant | 2 | 2 | 0 |
| QVB | Biological Sterilization Indicator With Indirect Growth Detection | 2 | 2 | 0 |
| SCS | Ultraviolet Radiation Disinfection Chamber Device | 2 | 2 | 0 |
| CAK | Microfilter, Blood Transfusion | 2 | 0 | 1 |
| FMS | Bed, Pediatric Open Hospital | 2 | 0 | 1 |
| FNJ | Bed, Manual | 1 | 0 | 1 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 2 | 0 | 1 |
| FPB | Filter, Infusion Line | 2 | 1 | 0 |
| FQM | Bandage, Elastic | 1 | 0 | 1 |
| FRF | Cleaner, Air, Medical Recirculating | 2 | 1 | 0 |
| GAG | Stapler, Surgical | 2 | 1 | 0 |
| KYW | Container, Liquid Medication, Graduated | 1 | 0 | 1 |
| KYZ | Syringe, Irrigating (Non Dental) | 1 | 0 | 1 |
| KZF | Device, Medical Examination, Ac Powered | 1 | 0 | 1 |
| LBI | Unit, Neonatal Phototherapy | 2 | 1 | 0 |
| LGM | Chamber, Patient Isolation | 2 | 1 | 0 |
| LWH | Counter, Sponge, Surgical | 1 | 0 | 1 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 | 0 |
| LZH | Pump, Infusion, Enteral | 2 | 1 | 0 |
| MEB | Pump, Infusion, Elastomeric | 2 | 1 | 0 |
| MHW | Dressing, Compression | 1 | 0 | 1 |
| MRH | Pump, Infusion, Ophthalmic | 2 | 1 | 0 |
| OJA | Intravenous Extension Tubing Set | 2 | 0 | 1 |
| OPP | Pump, Infusion, Insulin Bolus | 2 | 1 | 0 |
| OSI | Bariatric Bed | 2 | 0 | 1 |
| PBZ | Image Processing Device For Estimation Of External Blood Loss | 2 | 1 | 0 |
| PKP | Immunoglobulin G (Igg) Infusion System | 2 | 1 | 0 |
| PQH | Iodinated Contrast Media Transfer Tubing Set | 2 | 1 | 0 |
| PWR | Catheter Repair Kit | 2 | 0 | 1 |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | 2 | 0 | 1 |
| PXB | Percutaneous Introducer Kit | 2 | 0 | 1 |
| QLY | Ophthalmic Syringe | 2 | 1 | 0 |
| QNQ | Low Dead Space Piston Syringe | 2 | 1 | 0 |
| QXQ | Respiratory Accessory Microbial Reduction Device. | 2 | 1 | 0 |
| QYM | Ophthalmic Needle | 2 | 1 | 0 |
| SAK | Software Device To Aid In The Prediction Or Diagnosis Of Sepsis | 2 | 1 | 0 |
| SCL | Allergen And Vaccine Delivery Needles | 2 | 1 | 0 |
| SEW | Automated Endoscope Channel Cleaner | 2 | 1 | 0 |
| SGX | Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves | 2 | 1 | 0 |
| SHM | Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe | 2 | 1 | 0 |
| SIW | Robotic Peripheral Venous Blood Collection System | 2 | 1 | 0 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2026 | Cardinal Health 200, LLC Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: SWAN GANZ, KIT, CATALOG # PC37SGPHA Open, Classified |
OKE | None listed |
| Nov 2, 2026 | Cardinal Health 200, LLC Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) IV START LD KIT , CATALOG # IVS5342277;
2) IV S Open, Classified |
LRS | None listed |
| Oct 29, 2026 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. Carevo, Height-adjustable shower trolley, Model Number BAC1111-01 Open, Classified |
FSA | None listed |
| Oct 16, 2026 | B Braun Medical Inc B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068. Open, Classified |
FPA | K942988 |
| Oct 13, 2026 | Baxter Healthcare Corporation Likorall Overhead Lifts
Product Code: 3121001
Product Description: LIKORALL 200
Product Code: 3122005
Product Description: LIKORALL 242 ES, NATURAL
Product Code: 3122005NA
Product Description: LIKO Open, Classified |
FSA | None listed |
| Oct 9, 2026 | Ferno-Washington Inc Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821 Open, Classified |
FPO | None listed |
| Oct 2, 2026 | Safeguard US Operating LLC Battle Bandage, REF: 32-700;
Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL;
Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC;
Patrol IFAK II, Olive Drab, Stocked (Option 1), 81-129-OD;
IFAK B Open, Classified |
MHW | None listed |
| Oct 2, 2026 | Steris Corporation VERIFY Biological Steam Test Pack
Model/Catalog Number: S3069 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological Steam Test Pack
Model/Catalog Number: S3065 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicator
Model/Catalog Number: S3061 Open, Classified |
FRC | K083665 |
| Oct 2, 2026 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicator
Model/Catalog Number: S3060 Open, Classified |
FRC | K083665 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological/Integrator Challenge Pack
Model/Catalog Number: LCB007 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological/Integrator Challenge Pack
Model/Catalog Number: LCB006 Open, Classified |
FRC | K854902 |
| Oct 1, 2026 | Medline Industries, LP Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories
MDR107000P BED, MANUAL, MEDLITE Open, Classified |
FNJ | None listed |
| Oct 1, 2026 | Medline Industries, LP Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants:
MDR510094 PENDANT F/ MDR107002E
MDR520094 PENDANT F/ MDR107003E
MDR530094 PENDANT, W/ 9V BATTERY BACKUP, F/ 2E B Open, Classified |
LLI | None listed |
| Sep 25, 2026 | American Nitrile Operations Llc Brand Name: Opportunity Pro
Product Name: Opportunity Pro
Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804
Product Description: Blue Nitrile patient examination glove Open, Classified |
LZA | K220825 |
| Sep 25, 2026 | American Nitrile Operations Llc Brand Name: Opportunity Flex
Product Name: Opportunity Flex
Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904
Product Description: Blue Nitrile Patient examination gloves Open, Classified |
LZA | K220825 |
| Sep 25, 2026 | American Nitrile Operations Llc Brand Name: Performance Pro
Product Name: Performance Pro
Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604
Product Description: Blue Nitrile Patient examination gloves Open, Classified |
LZA | K220825 |
| Sep 22, 2026 | DeRoyal Industries Inc REF: 81-030415
Myocardial Probe Non-Pyrogenic , 400 Series Open, Classified |
FLL | K925792 |
| Sep 22, 2026 | Cardinal Health 200, LLC Presource Convenience Kits:
1) KIT, USGPIV , Catalog Number: PVMHIVMHD;
2) KIT, USGPIV , Catalog Number: PVMHIVM14;
3) KIT, USGPIV , Catalog Num Open, Classified |
OWL | None listed |
| Sep 17, 2026 | ICU Medical, Inc. CADD Yellow Medication Cassette Reservoir with NRFit connector
US Product Codes: 21-7600-24, 21-7609-24
OUS Product Codes:
21-7609-24
21-7600-24
21-7600-24
21-7600-24
21-7609-24
21-7609-24
21-7600-2 Open, Classified |
LHI | K162219 |
| Sep 16, 2026 | embecta Medical II LLC EWO_02513 (Catalog number 320122)
For Investigational Use Only
Nano Un-Cannulated Demo Samples
Quantity 100 Open, Classified |
FMI | K213478 |
| Sep 16, 2026 | embecta Medical II LLC EWO_02512 (Catalog number 320550)
For Investigational Use Only
Nano Pro Un-Cannulated Demo Samples
Quantity 100 Open, Classified |
FMI | K212015 |
| Sep 15, 2026 | Happiest Baby, Inc Happiest Baby, Inc. SNOO Sleep Sack, X-Large
Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512 S2101-513 S2101-532 S2101-533 S2101-534 Open, Classified |
QTG | None listed |
| Sep 15, 2026 | Happiest Baby, Inc Happiest Baby, Inc SNOO Sleep Sack, X-Small
Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110 Open, Classified |
QTG | None listed |
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