FDA recalls, August 2017: 597 published

108 different companies appear this month.

Risk classification: Class I: 69 · Class II: 476 · Class III: 52

Same month, other agencies:CPSC 23 recallsFSIS 14 recallsNHTSA 71 recalls

Recalls this month

DateProduct
August 16, 2017PALLAS M/MAXIMIS Ratchet T Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. …Z-3003-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst…Z-2917-2017Valorem Surgical LLC
August 16, 2017Piston Syringe, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/case The products are use…Z-2855-2017International Medsurg Connection, Inc.
August 16, 2017PALLAS M/MAXIMIS Open Extension (Small). Part of MAXIMIS Pedicle Screw Spinal Fixation Sy…Z-2984-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS Wall Check. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valor…Z-2964-2017Valorem Surgical LLC
August 16, 2017Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.0, 100 per box, 24 boxes/case, 2,…Z-2830-2017International Medsurg Connection, Inc.
August 16, 2017Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx…D-1079-2017Cantrell Drug Company
August 16, 2017PALLAS M/MAXIMIS 50mm Curved and precontoured Rod. Part of MAXIMIS Pedicle Screw Spinal F…Z-2943-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation Sys…Z-2908-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS MIS Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Scr…Z-2924-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation Sys…Z-2898-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS MIS Tapper 5.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. …Z-2982-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS 35mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem…Z-2955-2017Valorem Surgical LLC
August 16, 2017Piston Syringe, 3 CC L/S, 100 per box, 30 boxes/case, 3,000/case The products are used…Z-2852-2017International Medsurg Connection, Inc.
August 16, 2017Hypodermic Needle, 27 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The…Z-2821-2017International Medsurg Connection, Inc.
August 16, 2017J.J. LAWSON CHOCOLATE CHOC. CHIP ICE CREAM, 3 gallon round containerF-3364-2017Bliss Microcreamery, Inc.
August 16, 2017PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surg…Z-2961-2017Valorem Surgical LLC
August 16, 2017Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.0, 100 per box, 10 boxes/case, 1…Z-2848-2017International Medsurg Connection, Inc.
August 16, 2017Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Sing…D-1071-2017Cantrell Drug Company
August 16, 2017PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy…Z-2936-2017Valorem Surgical LLC
August 16, 2017Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.0, 100 per box, 24 boxes/case, 2,…Z-2832-2017International Medsurg Connection, Inc.
August 16, 2017Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Onl…D-1076-2017Cantrell Drug Company
August 16, 2017Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose …D-1058-2017Teva Pharmaceuticals USA
August 16, 2017PALLAS M/MAXIMIS 70mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. …Z-2945-2017Valorem Surgical LLC
August 16, 2017Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vi…D-1081-2017HOSPIRA INC, LAKE FOREST
August 16, 2017PALLAS M/MAXIMIS 80mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Val…Z-2889-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS Poly Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy…Z-2935-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS Rod Pusher B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Val…Z-3016-2017Valorem Surgical LLC
August 16, 2017Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.…D-1082-2017HOSPIRA INC, LAKE FOREST
August 16, 2017PALLAS M/MAXIMIS 40mm MIS rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Val…Z-2884-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS Extension Guide Bush. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst…Z-2989-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. Part of MAXIMIS Pedicle S…Z-3012-2017Valorem Surgical LLC
August 16, 2017Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.5, 100 per box, 24 boxes/case, 2,…Z-2829-2017International Medsurg Connection, Inc.
August 16, 2017MCCAIN ONION RING BATTERED PORTION PERFECT ¿ 60X4 ozF-3353-2017McCain Foods Canada, Inc.
August 16, 2017Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx O…D-1067-2017Cantrell Drug Company
August 16, 2017PALLAS M/MAXIMIS 400mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System…Z-2959-2017Valorem Surgical LLC
August 16, 2017Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Comp…D-1073-2017Cantrell Drug Company
August 16, 2017PALLAS M/MAXIMIS Inside Bender (L) and (R). Part of MAXIMIS Pedicle Screw Spinal Fixation…Z-2974-2017Valorem Surgical LLC
August 16, 2017Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose Syri…D-1069-2017Cantrell Drug Company
August 16, 2017PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Val…Z-2895-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Scr…Z-2929-2017Valorem Surgical LLC
August 16, 2017Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morri…D-1060-2017AtHome Medical, Inc.
August 16, 2017Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 100 per box, 24 boxes/case, 2…Z-2833-2017International Medsurg Connection, Inc.
August 16, 2017PALLAS M/MAXIMIS Polyaxial and MIS Screw, 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spina…Z-2911-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation Syste…Z-2925-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation Sys…Z-2909-2017Valorem Surgical LLC
August 16, 2017Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syri…D-1074-2017Cantrell Drug Company
August 16, 2017PALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valor…Z-3015-2017Valorem Surgical LLC
August 16, 2017BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and La…Z-2872-2017C.R. Bard, Inc.
August 16, 2017Piston Syringe, 60 CC L/S, 50 per box, 8 boxes/case, 400/case The products are used to…Z-2862-2017International Medsurg Connection, Inc.

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