Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

18176–18200 of 21645

ModerateFDA (Devices)·Z-1975-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides
Intuitive Surgical is recalling Natural Rubber Latex Quick Reference Guides for the da Vinci Surgical System to update documentation and remove a specific wrench part.
Product
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1972-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides
Intuitive Surgical is recalling Quick Reference Guides for the da Vinci Surgical System to remove the Emergency Grip Release Wrench from instructions.
Product
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1977-2014·2014-07-09
BD FACS Canto Flow Cytometer Recalled for Non-Operational Cooling Fans
BD Biosciences is recalling 35 BD FACS Canto flow cytometers and associated fluidics carts because the laser cooling fans and internal fans are not operational.
Product
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1982-2014·2014-07-09
Philips BrightView XCT Gamma Camera Recall for Flat Panel Display Defect
Philips Medical Systems is recalling 407 BrightView XCT and BrightView X- gamma cameras because the Flat Panel Display may fail to remain securely locked in the deployed position.
Product
BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging.
Category
Medical Device
Distribution
32 states
ModerateFDA (Devices)·Z-1968-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Stapler Addendum Documentation
Intuitive Surgical is recalling documentation for the da Vinci Surgical System stapler addendum to remove references to the Emergency Grip Release Wrench.
Product
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2055-2014·2014-07-09
Physique Enhancing Science Pre-Workout Recalled for Unapproved Ingredient
Physique Enhancing Science is recalling ENHANCED Ultra Advanced Pre-Workout supplements because they contain Aegeline, an unapproved new dietary ingredient.
Product
Physique Enhancing Science ENHANCED, Ultra Advanced Pre-Workout, DIETARY SUPPLEMENT Net Wt. 5.22 oz (148 g). In BlueRazz and Fruit Punch flavors
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1935-2014·2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1414-2014·2014-07-09
West-Ward Recalls Isoniazid Tablets Due to Dissolution Failure
West-Ward Pharmaceutical Corp. is recalling Isoniazid Tablets, USP, 300 mg because stability lots failed to meet dissolution specifications.
Product
Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1417-2014·2014-07-09
MD Custom Rx Recalls Diphenhydramine Solution Due to Incorrect Solvent
MD Custom Rx is recalling Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution because specific products were compounded with an incorrect solvent.
Product
Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-1836-2014·2014-07-09
Claymount Harmony2 Grid Cabinet Recalled for Labeling and Insulation Defects
Claymount Assemblies BV is recalling 12 Harmony2 grid cabinets because they lack required labeling information and have non-compliant insulation values.
Product
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated…
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-1970-2014·2014-07-09
Intuitive Surgical Recalls Vessel Sealer QRG for da Vinci Systems
Intuitive Surgical is recalling Vessel Sealer QRGs for da Vinci systems to remove the Emergency Grip Release Wrench from documentation.
Product
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1413-2014·2014-07-09
Baxter Recalls Brevibloc Injection Due to Particulate Matter
Baxter Healthcare is recalling Brevibloc (esmolol hydrochloride) injection due to complaints of discolored solution and subvisible iron oxide particles.
Product
BREVIBLOC — BREVIBLOC (ESMOLOL HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1973-2014·2014-07-09
Intuitive Surgical Recalls Cautery QRG for da Vinci Surgical Systems
Intuitive Surgical is recalling Cautery Quick Reference Guides for da Vinci systems to update documentation and remove a specific wrench part.
Product
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1420-2014·2014-07-09
MD Custom Rx Recalls HCG Drops Due to Incorrect Solvent
MD Custom Rx is recalling HCG drops compounded with an incorrect solvent. The recall covers specific lots distributed in Wisconsin.
Product
HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-2058-2014·2014-07-09
Roselani Tropics Kona Mud Pie Ice Cream Recalled for Incorrect Contents
Maui Soda & Ice Works is recalling 2,045 cartons of Roselani Tropics Kona Mud Pie Ice Cream because a complaint reported the cartons contained chocolate Macadamia Nut Ice Cream instead.
Product
Roselani Tropics Kona Mud Mud Pie Ice Cream: 1.75QT, - 56 oz. carton. Maui Soda & Ice Works, Ltd. Wailuku, HI
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-1942-2014·2014-07-09
Blue Belt Technologies Recalls Mislabeled Stride Unicondylar Knee Prosthesis Components
Blue Belt Technologies is recalling specific lots of Stride unicondylar knee prosthesis femoral components due to packaging mislabeling that may result in the wrong implant being used.
Product
Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1974-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides
Intuitive Surgical is recalling Quick Reference Guides for the da Vinci Surgical System to remove the Emergency Grip Release Wrench from the documentation.
Product
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1937-2014·2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1943-2014·2014-07-09
Blue Belt Technologies Recalls Mislabeled Stride Femoral Knee Components
Blue Belt Technologies is recalling two lots of Stride Femoral Knee Components due to packaging mislabeling that could lead to the implantation of the wrong side or size.
Product
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1962-2014·2014-07-09
Siemens ACUSON S Family Ultrasound Systems Recalled for Measurement Error
Siemens Medical Solutions is recalling ACUSON S Family ultrasound systems due to a potential measurement error in the Auto-Stats tool.
Product
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
Category
Medical Device
Distribution
5 states
ModerateFDA (Food)·F-2059-2014·2014-07-09
Brunkow Monterey Jack Cheese Recalled for Mushroom Mislabeling
Brunkow Cheese of Wisconsin is recalling Monterey Jack Morel Mushroom & Onion Cheese because it contains a different type of mushroom than listed on the label.
Product
Brunkow Cheese of Wisconsin, Monterey Jack Morel Mushroom & Onion Cheese, 5 lb block plastic wrapped and vacuum sealed. Eight blocks per case. Ingredients: Cultured Pasteurized Whole Milk, Salt, Microbial Enzymes, Morel Mushroom and Onion.
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-1926-2014·2014-07-02
Siemens Dimension LOCI Troponin I Calibrator Recalled for Result Shifts
Siemens is recalling Dimension LOCI Troponin I Calibrators because they may cause a 24% upward shift in test results.
Product
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1917-2014·2014-07-02
Anspach Custom Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1892-2014·2014-07-02
Anspach Custom MDA Tube Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Custom MDA Tubes because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1891-2014·2014-07-02
Anspach Nose Cone Cover Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Nose Cone Covers because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states