Core noun
Recalled products
The canonical enforcement rows. Everything else groups, enriches, or interprets these records.
Indexed record set
86,536 products
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- Product
- One Step P in vitro diagnostic test REF: 8194
- Firm
- DFI Co., Ltd.
- Event
- Event 98739
- Initiated
- April 02, 2026
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- Product
- QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
- Firm
- DFI Co., Ltd.
- Event
- Event 98739
- Initiated
- April 02, 2026
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- Product
- Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
- Firm
- Merit Medical Systems, Inc.
- Event
- Event 98637
- Initiated
- April 02, 2026
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- Product
- Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
- Firm
- Merit Medical Systems, Inc.
- Event
- Event 98637
- Initiated
- April 02, 2026
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- Product
- Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
- Firm
- Merit Medical Systems, Inc.
- Event
- Event 98637
- Initiated
- April 02, 2026
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- Product
- Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
- Firm
- Cook Incorporated
- Event
- Event 98682
- Initiated
- April 02, 2026
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- Product
- epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
- Firm
- Siemens Healthcare Diagnostics Inc
- Event
- Event 98680
- Initiated
- April 02, 2026
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- Product
- Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
- Firm
- Cook Incorporated
- Event
- Event 98682
- Initiated
- April 02, 2026
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- Product
- Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
- Firm
- Intuitive Surgical, Inc.
- Event
- Event 98564
- Initiated
- April 02, 2026
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- Product
- One Step 10A in vitro diagnostic test
- Firm
- DFI Co., Ltd.
- Event
- Event 98739
- Initiated
- April 02, 2026
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- Product
- One Step UTI in vitro diagnostic test REF: 3374
- Firm
- DFI Co., Ltd.
- Event
- Event 98739
- Initiated
- April 02, 2026
-
- Product
- One Step pH in vitro diagnostic test REF: 31I4P
- Firm
- DFI Co., Ltd.
- Event
- Event 98739
- Initiated
- April 02, 2026
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- Product
- Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
- Firm
- Cook Incorporated
- Event
- Event 98682
- Initiated
- April 02, 2026
-
- Product
- Uric Acid in vitro diagnostic test REF: 31H0P
- Firm
- DFI Co., Ltd.
- Event
- Event 98739
- Initiated
- April 02, 2026
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- Product
- One Step K in vitro diagnostic test REF: 81A4
- Firm
- DFI Co., Ltd.
- Event
- Event 98739
- Initiated
- April 02, 2026
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- Product
- Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)
- Firm
- Huons Co., Ltd.
- Event
- Event 98724
- Initiated
- April 02, 2026
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- Product
- LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
- Firm
- B BRAUN MEDICAL INC
- Event
- Event 98693
- Initiated
- April 02, 2026
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- Product
- Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)
- Firm
- Huons Co., Ltd.
- Event
- Event 98724
- Initiated
- April 02, 2026
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- Product
- Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)
- Firm
- Huons Co., Ltd.
- Event
- Event 98724
- Initiated
- April 02, 2026
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- Product
- Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
- Firm
- B BRAUN MEDICAL INC
- Event
- Event 98693
- Initiated
- April 02, 2026