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.

18151–18175 of 21645

ModerateFDA (Devices)·Z-1939-2014·2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer, Inc. 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 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1936-2014·2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer, Inc. 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 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1966-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Vision Troubleshooting Guides
Intuitive Surgical is recalling Vision Troubleshooting Guides for the da Vinci Surgical System to remove references to the Emergency Grip Release Wrench.
Product
Vision Troubleshooting Guide 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-1419-2014·2014-07-09
FDA Recalls HCG Tablets Compounded With Incorrect Solvent
FDA is recalling HCG 125U/Tab Tablet Tritu compounded by MD Custom Rx due to the use of an incorrect solvent.
Product
HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1421-2014·2014-07-09
MD Custom Rx Recalls HCG and Methylcobalamin Drops Due to Incorrect Solvent
MD Custom Rx is recalling HCG and Methylcobalamin drops because they were compounded with an incorrect solvent. The product was distributed in Wisconsin.
Product
HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1418-2014·2014-07-09
MD Custom Rx Recalls HCG Drops Due to Incorrect Solvent
MD Custom Rx is recalling HCG drops compounded with an incorrect solvent. The recall is limited to Wisconsin.
Product
HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-1945-2014·2014-07-09
Baxter MiniCap Dialysis Pouch Packaging Adhesion Defect Recall
Baxter Healthcare is recalling MiniCap dialysis pouches because the paper layer may not be fully adhered to the foil, potentially compromising the protective barrier.
Product
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1964-2014·2014-07-09
Intuitive Surgical Recalls da Vinci System Manuals Due to Wrench Removal
Intuitive Surgical is recalling da Vinci Surgical System manuals and guides to remove references to the Emergency Grip Release Wrench.
Product
System Manual 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-1941-2014·2014-07-09
Meridian Bioscience Recalls illumipro-10 Incubator/Reader Units for Calibration Issues
Meridian Bioscience is recalling 35 illumipro-10 incubator/reader units because Block B chambers may operate at incorrect temperatures due to calibration errors.
Product
illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.
Category
Medical Device
Distribution
17 states
ModerateFDA (Food)·F-2061-2014·2014-07-09
National Vitamin Recalls Ferrous Gluconate Tablets Due to Mislabeled Iron Content
National Vitamin Co Inc is recalling Nature's Blend Ferrous Gluconate Tablets because the front panel incorrectly lists 65 mg of elemental iron instead of the correct 36 mg.
Product
Ferrous Gluconate Tablets, 5gr (325 mg), Elemental Iron 36 mg, 100 Tablets, UPC 0 79854 50032 5
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1415-2014·2014-07-09
Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures
Caraco Pharmaceutical Laboratories is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, because stability results showed the product did not meet drug dissolution specifications.
Product
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1967-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Surgical System Instrument Release Kits
Intuitive Surgical is recalling Instrument Release Kits for the da Vinci Surgical System to remove the Emergency Grip Release Wrench.
Product
Insert for IRK 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-1965-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Endowrist Instrument Manuals
Intuitive Surgical is recalling Endowrist Instrument and Accessory Manuals for the da Vinci Surgical System to remove the Emergency Grip Release Wrench.
Product
Endowrist Instrument and Accessory Manual 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-1984-2014·2014-07-09
Synthes B37 Replacement Screws Recalled for Potential Mislabeling
Synthes, Inc. is recalling 44 B37 Replacement Screws because the package may not contain the screws identified on the label.
Product
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1980-2014·2014-07-09
Nidek AFC-330 Fundus Camera Recalled for Image Defects
Nidek Inc. is recalling 185 AFC-330 Non-Mydriatic Auto Fundus Cameras because images may contain white spots that could affect diagnosis.
Product
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1416-2014·2014-07-09
Mometasone Irrigation Solution Recalled for Incorrect Solvent
MD Custom Rx is recalling Mometasone irrigation solution compounded with an incorrect solvent. The product was distributed in Wisconsin.
Product
Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-1958-2014·2014-07-09
Focus Diagnostics Recalls Simplexa Flu A/B & RSV Direct Assay Kits
Focus Diagnostics is correcting labeling for 614 Simplexa Flu A/B & RSV Direct kits due to sporadic false signals that may increase false results.
Product
Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1412-2014·2014-07-09
Forest Pharmaceuticals Recalls Bystolic Tablets for Dissolution Failure
Forest Pharmaceuticals is recalling Bystolic (nebivolol) 20 mg tablets because they failed stage III dissolution testing. The recall affects 92,544 bottles distributed nationwide.
Product
Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2054-2014·2014-07-09
Physique Enhancing Science Recalls ALPHAMINE Powder Due to Unapproved Ingredient
Physique Enhancing Science is recalling ALPHAMINE thermogenic powder because it contains Aegeline, an unapproved new dietary ingredient.
Product
Physique Enhancing Science ALPHAMINE, Powerful Thermogenic Powder, DIETARY SUPPLEMENT Net Wt. 8.9 oz (252 g). Raspberry Lemonade and Fruit Punch flavors.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1969-2014·2014-07-09
Intuitive Surgical Recalls Vessel Sealer Addendum for da Vinci Systems
Intuitive Surgical is recalling Vessel Sealer Addendum software for da Vinci surgical systems to update user manuals and remove the Emergency Grip Release Wrench.
Product
Vessel Sealer 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 (Devices)·Z-1946-2014·2014-07-09
Origio Pasteur Pipets Recalled Due to Packaging Sterility Breach
Origio, Inc. is recalling Pasteur Pipets used in IVF laboratories because a breach in the nylon pouch sterile barrier was identified.
Product
Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1932-2014·2014-07-09
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 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1971-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Manuals Due to Wrench Removal
Intuitive Surgical is recalling da Vinci Surgical System manuals to remove the Emergency Grip Release Wrench from the documentation.
Product
Single Site US Manuals and Single Site OUS Manuals 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-1934-2014·2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer, Inc. 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 (Devices)·Z-1933-2014·2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer, Inc. 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 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Category
Medical Device
Distribution
Distributed nationwide