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.

13301–13325 of 21617

ModerateFDA (Devices)·Z-0997-2017·2017-01-18
Siemens Biograph mCT X-3R Scanners Recalled for Falling Laser Cover Windows
Siemens Medical Solutions is recalling 18 Biograph mCT X-3R scanners because laser cover windows may fall off.
Product
Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0948-2017·2017-01-11
Tepha GalaSHAPE 3D Medical Device Recalled for Endotoxin Specification Exceedance
Tepha Incorporated is recalling 29 units of GalaSHAPE 3D medical devices because endotoxin levels slightly exceeded specifications.
Product
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1173-2017·2017-01-11
Eby Brown Recalls Italian Sub Sandwiches Due to Molding
Eby Brown Co is recalling 4,171 Italian Sub sandwiches because a customer reported the product was molding before its expiration date.
Product
ITALIAN SUB Net Wt 5.5 oz (155g) Smoked ham, hard salami, pepperoni with provolone cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 67597 5
Category
Food
Distribution
15 states
ModerateFDA (Food)·F-1175-2017·2017-01-11
Eby-Brown Recalls Moldy Big Stack Sub Sandwiches
Eby-Brown is recalling Big Stack Sub sandwiches after a customer reported the product was molding before its expiration date.
Product
THE BIG STACK SUB Net Wt 6.4 oz (181g) Roast beef, oven roasted turkey, smoked ham, hard salami with Swiss cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 67593 7
Category
Food
Distribution
15 states
ModerateFDA (Food)·F-1169-2017·2017-01-11
Eby Brown Recalls American Classic Subs Due to Molding Before Expiration
Eby Brown Co is recalling 3,268 American Classic Subs because a customer reported the product was molding before its expiration date.
Product
AMERICAN CLASSIC SUB Net Wt 6.5 oz (184g) Smoked ham, deli style bologna, hard salami with American and Swiss cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 67594 4
Category
Food
Distribution
15 states
ModerateFDA (Food)·F-1172-2017·2017-01-11
Eby-Brown Recalls Ham and Swiss Pretzel Subs Due to Mold
Eby-Brown is recalling 1,422 Ham & Swiss Pretzel Subs because a customer reported the product was molding before its expiration date.
Product
HAM & SWISS PRETZEL SUB Net Wt 6.4 oz (181g) Thin sliced smoked ham piled high on a split top pretzel roll, topped with mild, nutty Swiss cheese KEEP REFRIGERATED UPC 6 42984 98519 7
Category
Food
Distribution
15 states
ModerateFDA (Drugs)·D-0245-2017·2017-01-11
Apotex Recalls Torsemide Tablets Due to Manufacturing Deviations
Apotex Corp. is voluntarily recalling Torsemide Tablets, 5 mg, due to Current Good Manufacturing Practice (CGMP) deviations. The recall covers 13,179 bottles distributed in the United States.
Product
Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-0949-2017·2017-01-11
Merit PreludeEASE Hydrophilic Sheath Introducer Dilator Recall
Merit Medical Systems is recalling 335 PreludeEASE Hydrophilic Sheath Introducer Dilators because the tips are undersized and cannot pass a 0.021-inch guide wire.
Product
PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1163-2017·2017-01-11
Midwest International Longan Aril Recalled for Unsafe Food Additives
Midwest International Corp is recalling Longan Aril because it contains unsafe food additives and undeclared colorants.
Product
LONGAN ARIL, Net Wt: 7.4oz (210g), contains yellow and orange labeling
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1176-2017·2017-01-11
Eby-Brown Recalls Turkey and Cheese Sandwiches Due to Mold
Eby-Brown is recalling specific lots of Turkey & Cheese Sandwiches because a customer reported the product was molding before the expiration date.
Product
TURKEY & CHEESE SANDWICH Net Wt 4,7 oz (133g) Savory turkey & cheese on wheat bread KEEP REFRIGERATED UPC 6 42984 67592 0
Category
Food
Distribution
15 states
ModerateFDA (Food)·F-1171-2017·2017-01-11
Eby-Brown Recalls Chicken Salad Sandwiches Due to Mold
Eby-Brown is recalling 4,712 chicken salad sandwiches because a customer reported the product was molding before its expiration date.
Product
CHICKEN SALAD SANDWICH Net Wt 4.5 oz (128g) Chunky chicken salad on wheat bread KEEP REFRIGERATED UPC 6 42984 67589 0
Category
Food
Distribution
15 states
ModerateFDA (Drugs)·D-0242-2017·2017-01-11
Gentell Hydrogel Ag Saturated Gauze Recalled for CGMP Deviations
Gentell, Inc. is voluntarily recalling 3,000 units of Hydrogel Ag Saturated Gauze in three sizes due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0243-2017·2017-01-11
Gentell Hydrogel Wound Dressing Recalled for CGMP Deviations
Gentell, Inc. is voluntarily recalling Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tubes due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-1178-2017·2017-01-11
Eby-Brown Recalls Tuna Salad Sandwiches Due to Molding
Eby-Brown is recalling Tuna Salad Sandwiches after a customer reported the product was molding before its expiration date.
Product
TUNA SALAD SANDWICH Net Wt 4.5 oz (128g) Creamy tuna salad on wheat bread KEEP REFRIGERATED UPC 6 42984 67588 3
Category
Food
Distribution
15 states
ModerateFDA (Drugs)·D-0244-2017·2017-01-11
Apotex Recalls Torsemide Tablets Due to Manufacturing Deviations
Apotex Corp. is voluntarily recalling Torsemide Tablets 20 mg due to CGMP deviations. The recall covers 35,819 bottles distributed in the United States.
Product
Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-1181-2017·2017-01-11
Market Pantry Peanut Butter Cookies Recalled for Incorrect Labeling
Minnesota Best Maid Cookie Co. is recalling Market Pantry Peanut Butter Cookies because the containers have an incorrect bottom label.
Product
Market Pantry Peanut Butter Cookies. Net Wt. 10.8 oz (306g) UPC 92180 11707
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0943-2017·2017-01-11
MicroPort Orthopedics Recalls Profemur R Rasp Handles Due to Machining Issues
MicroPort Orthopedics is recalling 20 units of Profemur R Rasp Handles because machining issues may prevent them from properly mating with broaches.
Product
PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·F-1170-2017·2017-01-11
Eby-Brown Recalls Chicken and Cheese Subs Due to Mold
Eby-Brown is recalling 741 Chicken and Cheese Subs because a customer reported the product was molding before its expiration date.
Product
CHICKEN AND CHEESE SUB Net Wt 6.4 oz (181g) Oven cooked chicken with American cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 98518 0
Category
Food
Distribution
15 states
ModerateFDA (Food)·F-1177-2017·2017-01-11
Eby-Brown Recalls Turkey and Cheese Subs Due to Mold
Eby-Brown is recalling 3,351 Turkey & Cheese Subs because a customer reported the product was molding before its expiration date.
Product
TURKEY & CHEESE SUB Net Wt 5.9 oz (167g) Oven roasted turkey with American cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 67595 1
Category
Food
Distribution
15 states
ModerateFDA (Food)·F-0856-2017·2017-01-11
Mitsui Foods Recalls Fresh Catch Smoked Baby Clams Due to Seal Quality Issue
Mitsui Foods Inc is recalling Fresh Catch Smoked Baby Clams because a packaging seal defect may allow the food to spoil and cause package swelling.
Product
Fresh Catch Smoked Baby Clams 3.53 oz. pouch (100g) Item Number 541187381, UPC 087381043895
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-1174-2017·2017-01-11
Eby Brown Recalls Smoked Ham and Cheese Subs Due to Mold
Eby Brown is recalling 3,126 smoked ham and cheese subs after a customer reported mold before the expiration date. The product was distributed to 15 states.
Product
SMOKED HAM & CHEESE SUB Net Wt 5.9 oz (167g) Smoked ham with American cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 67596 8
Category
Food
Distribution
15 states
ModerateFDA (Devices)·Z-0940-2017·2017-01-11
Infraredx Recalls TVC Imaging System Due to Image Appearance Issues
Infraredx, Inc. is recalling seven TVC Imaging System units because near-infrared images sometimes displayed lipid core plaques with an unusual horizontal orientation.
Product
TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using…
Category
Medical Device
Distribution
1 state
ModerateNHTSA·17V008000·2017-01-09
Heartland Recalls 2017 Mallard Trailers for Incorrect Certification Label
Heartland is recalling 2017 Mallard recreational trailers because the certification label may contain incorrect tire size or pressure information, which could lead to improper tire inflation or overloading.
Product
HEARTLAND — HEARTLAND MALLARD
Category
Vehicle
Distribution
Distributed nationwide
ModerateUSDA FSIS·001-2017·2017-01-05
4G Meat Processing Recalls Italian Sausage for Misbranding and Missing Labels
4G Meat Processing LLC is recalling approximately 1,288 pounds of pork and turkey Caldarello Italian Sausage because the products contain undeclared MSG and lack required ingredients and safe handling statements on individual packages.
Product
4G Meat Processing LLC — Recall Notification Report 001-2017 (Italian Sausage)
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-0902-2017·2017-01-04
PerkinElmer Recalls Specimen Gate Laboratory Software Due to Disk Space Issue
PerkinElmer Health Sciences is recalling 21 units of Specimen Gate Laboratory and eReports software because a defect may cause excessive disk space consumption, leading to software failure.
Product
Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module…
Category
Medical Device
Distribution
12 states