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DeRoyal
DEROYAL INDUSTRIES, INC. · Model 32-2059 · UDI-DI 00749756869232
GDY
Prescription
10
510(k) clearances
2,521
Adverse events (3 deaths)
66
Recalls
209
Facilities
Description
Super Kerlix Sponges 36/PK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2025-07-01 | Carefree Surgical Specialties | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging |
| 2025-07-01 | Carefree Surgical Specialties | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging |
| 2025-07-01 | Carefree Surgical Specialties | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging |
| 2025-07-01 | Carefree Surgical Specialties | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging |
| 2024-02-21 | Covidien | Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't |
| 2022-01-24 | Argon Medical Devices, Inc | Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor bl |
| 2021-08-11 | Cypress Medical Products LLC | Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators di |
| 2020-04-08 | Argon Medical Devices, Inc | Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may |
| 2020-04-08 | Argon Medical Devices, Inc | Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.