510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,528 records, page 508 of 1191
FDA device recalls, page 508 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3115-2017Class IISpectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The...Implant Direct Sybron Manufacturing LLCLXH
Z-3074-2017Class IIPOLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a)...Kentec Medical, LLCFPD
Z-3073-2017Class IIPOLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b)...Kentec Medical, LLCFPD
Z-2862-2017Class IIPiston Syringe, 60 CC L/S, 50 per box, 8 boxes/case, 400/case The products are used to...Intl. Medsurg Connection, Inc.FMF
Z-2861-2017Class IIPiston Syringe, 60 CC L/L, 50 per box, 8 boxes/case, 400/case The products are used to...Intl. Medsurg Connection, Inc.FMF
Z-2860-2017Class IIPiston Syringe, 30 CC L/S, 50 per box, 9 boxes/case, 450/case The products are used to...Intl. Medsurg Connection, Inc.FMF
Z-2859-2017Class IIPiston Syringe, 30 CC L/L, 50 per box, 9 boxes/case, 450/case The products are used to...Intl. Medsurg Connection, Inc.FMF
Z-2858-2017Class IIPiston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/case The products are used to...Intl. Medsurg Connection, Inc.FMF
Z-2857-2017Class IIPiston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/case The products are used to...Intl. Medsurg Connection, Inc.FMF
Z-2856-2017Class IIPiston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The products are used...Intl. Medsurg Connection, Inc.FMF
Z-2855-2017Class IIPiston Syringe, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/case The products are used...Intl. Medsurg Connection, Inc.FMF
Z-2854-2017Class IIPiston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The products are used to...Intl. Medsurg Connection, Inc.FMF
Z-2853-2017Class IIPiston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/case The products are used...Intl. Medsurg Connection, Inc.FMF
Z-2852-2017Class IIPiston Syringe, 3 CC L/S, 100 per box, 30 boxes/case, 3,000/case The products are used...Intl. Medsurg Connection, Inc.FMF
Z-2851-2017Class IIPiston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The products are used...Intl. Medsurg Connection, Inc.FMF
Z-2850-2017Class IIPiston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/case The products are used...Intl. Medsurg Connection, Inc.FMF
Z-2849-2017Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.5, 100 per box, 10 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2848-2017Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.0, 100 per box, 10 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2847-2017Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.5, 100 per box, 10 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2846-2017Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.0, 100 per box, 10 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2845-2017Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, 100 per box, 10 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2844-2017Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.0, 100 per box, 10 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2843-2017Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.5, 100 per box, 15 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2842-2017Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2841-2017Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.5, 100 per box, 15 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2840-2017Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.0, 100 per box, 15 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2839-2017Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2838-201Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.0, 100 per box, 15 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2837-201Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 5/8, 100 per box, 24 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2836-201Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 1.0, 100 per box, 24 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2835-201Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 23 G X 1.0, 100 per box, 24 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2834-2017Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.5, 100 per box, 24 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2833-2017Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 100 per box, 24 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2832-2017Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.0, 100 per box, 24 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2831-2017Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.5, 100 per box, 24 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2830-2017Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.0, 100 per box, 24 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2829-2017Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.5, 100 per box, 24 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2828-2017Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.0, 100 per box, 24 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2827-2017Class IIPiston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2826-2017Class IIPiston Syringe and Hypodermic Needle, 1 CC TB 27 G X 0.5, 100 per box, 30 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2825-2017Class IIPiston Syringe and Hypodermic Needle, 1 CC TB 25 G X 5/8, 100 per box, 30 boxes/case...Intl. Medsurg Connection, Inc.FMF
Z-2824-2017Class IIHypodermic Needle, 30 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The...Intl. Medsurg Connection, Inc.FMI
Z-2823-2017Class IIHypodermic Needle, 30 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The...Intl. Medsurg Connection, Inc.FMI
Z-2822-2017Class IIHypodermic Needle, 27 G X 1.5 in HYPODERMIC, 100 per box, 50 boxes/case, 5,000/case The...Intl. Medsurg Connection, Inc.FMI
Z-2821-2017Class IIHypodermic Needle, 27 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The...Intl. Medsurg Connection, Inc.FMI
Z-2820-2017Class IIHypodermic Needle, 27 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The...Intl. Medsurg Connection, Inc.FMI
Z-2819-2017Class IIHypodermic Needle, 25 G X 5/8 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The...Intl. Medsurg Connection, Inc.FMI
Z-2818-2017Class IIHypodermic Needle, 25 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The...Intl. Medsurg Connection, Inc.FMI
Z-2817-2017Class IIHypodermic Needle, 25 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The...Intl. Medsurg Connection, Inc.FMI
Z-2816-2017Class IIHypodermic Needle, 23 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The...Intl. Medsurg Connection, Inc.FMI