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.

14551–14575 of 21645

ModerateFDA (Food)·F-1412-2016·2016-06-08
O'Steen Meat Specialties Recalls Spicy Mac & Cheese Bites Due to Plastic Inclusion
O'Steen Meat Specialties is recalling 847 cases of Spicy Mac & Cheese Bites because they may contain pieces of plastic. The product was distributed in seven states.
Product
Code 2013 Spicy Mac & Cheese Bites Breaded Macaroni & Monterey Jack Cheese O 'Steen Meat Specialties Inc. 2126 N. Broadway Oklahoma City, OK 73103 Phone (405) 236-1952 KEEP FROZEN Net Weight 10 LBS. UPC: 7-49616-02013-1
Category
Food
Distribution
7 states
ModerateFDA (Devices)·Z-1845-2016·2016-06-08
Olympus Recalls Duodenoscopes for New Reprocessing Instructions
Olympus Corporation of the Americas is recalling TJF-160F and TJF-160VF duodenoscopes to provide new reprocessing instructions and a cleaning brush.
Product
EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1872-2016·2016-06-08
Philips Brilliance 64 CT Systems Recalled for Software Mapping Error
Philips Medical Systems is recalling 158 Brilliance 64 CT systems because the software may fail to map the Varian drive after a user logs out and back in.
Product
Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce 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-1901-2016·2016-06-08
Exactech Recalls Two Novation Ceramic Hip Acetabular Cups
Exactech is recalling two Novation Ceramic AHS Cluster-Hole Shell acetabular cups because they were packaged before regulatory approval.
Product
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
Category
Medical Device
Distribution
9 states
ModerateFDA (Drugs)·D-0950-2016·2016-06-08
Taro Recalls Subpotent Topicort Cream Tubes in Multiple States
Taro Pharmaceuticals is recalling 62,800 tubes of Topicort cream because the medication contained less active ingredient than labeled.
Product
¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC…
Category
Drug
Distribution
9 states
ModerateFDA (Devices)·Z-1876-2016·2016-06-08
Leica Novocastr Antibody Recalled for Stability Issues
Leica Microsystems is recalling 270 units of Novocastr Liquid Mouse Monoclonal Antibody RCC because testing showed the product is not stable up to its labeled expiry date.
Product
Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-1904-2016·2016-06-08
Exactech Recalls One Novation Femoral Stem Device for Premature Packaging
Exactech is recalling one Novation femoral stem device because it was packaged before the required site-change approval was granted.
Product
Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-1865-2016·2016-06-08
Abbott ARCHITECT Estradiol Kit Recalled for Fulvestrant Interference
Abbott Laboratories is recalling ARCHITECT Estradiol Kits because interaction with the drug Fulvestrant causes falsely elevated estradiol results.
Product
The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Category
Medical Device
Distribution
42 states
ModerateFDA (Devices)·Z-1840-2016·2016-06-08
Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues
Baxter Healthcare is recalling 6,128 COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.
Product
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1838-2016·2016-06-08
Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues
Baxter Healthcare is recalling 274 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.
Product
COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1905-2016·2016-06-08
Exactech Recalls Novation Femoral Stems Due to Premature Packaging
Exactech is recalling nine Novation femoral stems because they were packaged before receiving FDA approval for a site change.
Product
Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-1903-2016·2016-06-08
Exactech Recalls One Novation Femoral Stem for Premature Packaging
Exactech is recalling one Novation femoral stem device because it was packaged before the required FDA site-change approval was granted.
Product
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-1843-2016·2016-06-08
Medscience AllergiEnd Skin Test Applicators Recalled for Lack of Clearance
Medscience Inc is recalling AllergiEnd ST-9 skin test applicators and trays because they were marketed without FDA clearance.
Product
AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1834-2016·2016-06-08
MicroAire Pneumatic Impactor Recall for Missing Symbol Markings
MicroAire is recalling 20 Pneumatic Impactor units because they are missing required lock and unlock symbol markings.
Product
Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1874-2016·2016-06-08
Philips Ingenuity Core 128 CT Systems Recalled for Drive Mapping Issue
Philips Medical Systems is recalling 424 Ingenuity Core 128 CT systems because the system may not map the Varian drive after a user logout and login.
Product
Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce 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-1875-2016·2016-06-08
Philips Ingenuity CT Systems Recalled for Drive Mapping Issue
Philips is recalling 215 Ingenuity CT systems because they may fail to map the Varian drive after a user logs out and back in.
Product
Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce 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-1900-2016·2016-06-08
Exactech Recalls Three Ceramic Hip Acetabular Cups Due to Premature Packaging
Exactech is recalling three Novation Ceramic AHS Cluster-Hole Shells because they were packaged before the required site-change approval was granted.
Product
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-1839-2016·2016-06-08
Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues
Baxter Healthcare is recalling 6,804 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.
Product
COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1877-2016·2016-06-08
Leica Microsystems Recalls Unstable CDX2 Antibody Lots
Leica Microsystems is recalling specific lots of Novocastr CDX2 antibody because testing showed they are not stable until their expiration dates.
Product
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-1902-2016·2016-06-08
Exactech Recalls Four Novation Femoral Stems Due to Premature Packaging
Exactech is recalling four Novation femoral stems because they were packaged before the required site-change approval was granted.
Product
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.
Category
Medical Device
Distribution
9 states
ModerateFDA (Drugs)·D-0874-2016·2016-06-01
Akorn Recalls ORIS Chlorhexidine Oral Rinse Due to Impurity
Akorn, Inc. is recalling ORIS (chlorhexidine gluconate) oral rinse because multiple batches failed impurity specifications.
Product
ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1389-2016·2016-06-01
Nubreed Nutrition Recalls Undisputed Dietary Supplement Due to Non-Compliant Ingredient
Nubreed Nutrition is voluntarily recalling Undisputed dietary supplements because they contain Acacia rigidula, which does not meet the definition of a dietary ingredient.
Product
Undisputed , all lot codes, Flavors: Mango Orange , 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-1388-2016·2016-06-01
Nubreed Nutrition Recalls Undisputed Dietary Supplement for Non-Compliant Ingredient
Nubreed Nutrition is voluntarily recalling Undisputed dietary supplements because they contain Acacia rigidula, an ingredient that does not meet FDA dietary ingredient definitions.
Product
Undisputed , all lot codes, Flavors: Juicy Pineapple, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-1797-2016·2016-06-01
American Surgical Uniqcot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 15 cases distributed worldwide.
Product
American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1385-2016·2016-06-01
Nubreed Nutrition Recalls Undisputed Dietary Supplement for Improper Ingredient
Nubreed Nutrition is voluntarily recalling Undisputed dietary supplements because they contain Acacia rigidula, an ingredient that does not meet the definition of a dietary ingredient.
Product
Undisputed , all lot codes, Flavors:Fruit Punch, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
Category
Food
Distribution
0 states