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.

13801–13825 of 21617

ModerateFDA (Drugs)·D-0083-2017·2016-10-19
Pharmedium Recalls Neostigmine Methylsulfate Syringes Due to Stability Concerns
Pharmedium Services, LLC is recalling specific lots of neostigmine methylsulfate syringes because stability data does not support the expiration dates, posing a risk of reduced potency.
Product
neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0082-2017·2016-10-19
Pharmedium Recalls Neostigmine Methylsulfate Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 2,105 syringes of neostigmine methylsulfate because stability data does not support the expiration dates, posing a risk of reduced potency.
Product
neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3326.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0065-2017·2016-10-19
PharMEDium Lidocaine Syringes Recalled for Potential Loss of Potency
PharMEDium is recalling lidocaine HCl syringes because stability data does not support the expiration dates, posing a risk of reduced drug potency.
Product
lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3112.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0005-2017·2016-10-12
Teva Recalls Claravis Isotretinoin Capsules Due to Impurity Failures
Teva North America is recalling Claravis (isotretinoin) capsules because they failed impurity and degradation specifications.
Product
Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0024-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A3.5 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 17 units of Zenostar MT Color A3.5 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0047-2017·2016-10-12
Toshiba Aquilion RXL CT Scanner Recalled for Reconstruction Error
Toshiba is recalling 165 Aquilion RXL CT scanners because a reconstruction error may interrupt scans if the range exceeds the maximum field of view.
Product
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-2906-2016·2016-10-12
Integra CUSA Dissectron Fingertip Laparoscopic Cannula Recalled for Packaging Seal Defect
Integra LifeSciences is recalling 9 units of CUSA Dissectron Fingertip Laparoscopic Cannulas due to incomplete sterile packaging seals discovered during final inspection.
Product
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0042-2017·2016-10-12
Wegmans Italian Classics Ricotta & Spinach Ravioli Recalled for Plastic Contamination
Wegmans is recalling Italian Classics Ricotta & Spinach Striped Jumbo Ravioli because the product may contain pieces of white plastic.
Product
Wegmans ITALIAN CLASSICS RICOTTA & SPINACH STRIPED JUMBO RAVIOLI, NET WT 9 OZ. (255g), UPC 0-77890-38934, KEEP REFRIGERATED -- Distributed By: Wegmans Foods Markets, Inc. Rochester, NY 14603, Product of Canada --- Packaged in a plastic tray and sold in a refrigerated case in the…
Category
Food
Distribution
6 states
ModerateFDA (Drugs)·D-0008-2017·2016-10-12
West-Ward Recalls Prednisone Tablets Due to Underweight Specification Failure
West-Ward Pharmaceuticals is recalling 15,109 bottles of Prednisone 1 mg tablets because an underweight tablet was discovered.
Product
PREDNISONE — PREDNISONE (PREDNISONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0018-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Brown Dental Porcelain
Ivoclar Vivadent is recalling 11 units of Zenostar MT Color Impulse brown dental porcelain due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0012-2017·2016-10-12
Philips Ingenuity CT Scanner Recalled for Infant Head Image Quality Issues
Philips Medical Systems is recalling 235 Ingenuity CT scanners because infant head scans in High Resolution mode may produce degraded image quality, including non-uniformity and CT number shifts.
Product
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0017-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Blue Dental Porcelain
Ivoclar Vivadent is recalling 79 units of Zenostar MT Color Impulse blue dental porcelain due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0032-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C3 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 13 units of Zenostar MT Color C3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0049-2017·2016-10-12
Toshiba Celesteion CT Scanner Recalled for Potential Reconstruction Errors
Toshiba is recalling 165 Celesteion CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum field of view.
Product
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-0028-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B3 Dental Porcelain Liquid
Ivoclar Vivadent is recalling 27 units of Zenostar MT Color B3 dental porcelain liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0048-2017·2016-10-12
Toshiba Aquilion LB CT Scanner Recalled for Reconstruction Error
Toshiba is recalling 165 Aquilion LB CT scanners because a reconstruction error may interrupt scanning if the range exceeds the maximum field of view.
Product
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-0027-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 15 units of Zenostar MT Color B2 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2833-2016·2016-10-12
TriFoillmaging CT Scanners Recalled for X-Ray Compliance Issues
Northridge Tri-Modality Imaging is recalling three TriFoillmaging Triumph/Triumph II Research CT scanners because they may not meet federal X-ray safety standards.
Product
TriFoillmaging Triumph/Triumph II Research CT scanners.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0026-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B1 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 43 units of Zenostar MT Color B1 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0035-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color D3 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 18 units of Zenostar MT Color D3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0001-2017·2016-10-12
Ballester Hermanos Recalls Canned Octopus in Oil Due to Mislabeling
Ballester Hermanos, Inc. is recalling canned octopus in oil because the product is actually squid. The recall covers Puerto Rico.
Product
Product in cans of 4 1/4 oz (111g) and 8 1/4 oz (220g) net weight. Label reading in part as: "Coloso***PULPO EN ACEITE***OCTOPUS IN OIL***NET WEIGHT ***Fabricado en Espa¿a (Manufactured in Spain)***Packed by: POYO PONTEVEDRA SPAIN***PACKED FOR COLOSO FOODS, INC.*** MERCADO…
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-0036-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color D4 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 9 units of Zenostar MT Color D4 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0033-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C4 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 10 units of Zenostar MT Color C4 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0023-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A3 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 42 units of Zenostar MT Color A3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2916-2016·2016-10-12
New Star Lasers Recalls ReNew Dermatology Devices for Labeling Errors
New Star Lasers is recalling five ReNew laser systems because customers were not notified when promotional material was revised to remove outside-use indications.
Product
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of…
Category
Medical Device
Distribution
0 states