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.

13826–13850 of 21617

ModerateFDA (Food)·F-0004-2017·2016-10-12
Ballester Hermanos Recalls Canned Octopus in Puerto Rico Due to Mislabeling
Ballester Hermanos, Inc. is recalling 145 cases of canned octopus in Puerto Rico because the product contains squid instead of octopus.
Product
Product in cans of 4 1/4 oz and 8 1/4 oz net weight. Label reading in part as: "Coloso***PULPO EN SALSA MARINERA***OCTOPUS IN PICKLED SAUCE***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 (Food)·F-2642-2016·2016-10-12
Coca-Cola Recalls Sprite Cans Due to Tab Opening Upward
The Coca-Cola Company is recalling specific Sprite and Sprite Zero cans where the tab may open upward instead of downward, causing a loud pop.
Product
Sprite Zero, 12 oz. can/12 pack, UPC 049000037111; Sprite, 12 oz. can/6 pack, UPC N/A; Sprite, 12 oz. can/12 pack, UPC 049000028928; Sprite, 12 oz. can/20 pack, UPC 049000014655
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0050-2017·2016-10-12
Randox IgE Calibrator Series Recall for Value Alignment
Randox Laboratories is recalling IgE Calibrator Series units to align value assignments with the 3rd International Standard for human serum IgE.
Product
IgE Calibrator Series
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2914-2016·2016-10-12
New Star Lasers Recalls CT3Plus and CT3PZ Systems for Labeling Issues
New Star Lasers is recalling 91 CT3Plus and CT3PZ laser systems because customers were not notified when promotional labeling was revised to remove outside-use indications.
Product
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0034-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color D2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 40 units of Zenostar MT Color D2 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0022-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling Zenostar MT Color A2 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Product
Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0003-2017·2016-10-12
Ballester Hermanos Recalls Canned Octopus in Hot Oil Due to Mislabeling
Ballester Hermanos, Inc. is recalling 166 cases of canned octopus in hot oil sold in Puerto Rico because the label lists octopus but the product contains squid.
Product
Product in cans of 4 1/4 oz and 8 1/4 oz net weight. Label reading in part as: "Coloso***PULPO EN ACEITE PICANTE***OCTOPUS IN HOT 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 (Food)·F-2641-2016·2016-10-12
Coca-Cola Cans Recalled Due to Tab Opening Upward
The Coca-Cola Company is recalling 14,168 cases of various soda cans where the tab may open upward instead of downward, causing a loud pop.
Product
Coca-Cola, 16 fl. oz. can/12 pack, UPC 049000054318; Coca-Cola, 12 oz. can/12 pack, UPC 049000028904; Coca-Cola Zero, 12 oz. can/12 pack, UPC 049000042559; Diet Coke, 12 oz. can/24 pack, UPC 049000010633; Diet Coke, 12 oz. can/12 pack, UPC 049000028911; Cherry Coke, 12 oz.…
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0021-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A1 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling Zenostar MT Color A1 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Product
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0030-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C1 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 37 units of Zenostar MT Color C1 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Product
Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2907-2016·2016-10-12
Integra Lumbar Drainage Set Recalled for Incomplete Packaging Seal
Integra LifeSciences is recalling 18 units of Integral Lumbar Drainage Sets due to incomplete sterile packaging seals discovered during final inspection.
Product
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0010-2017·2016-10-12
Philips CT Scanner Recall for Infant Head Image Quality Defects
Philips is recalling 358 Ingenuity Core CT scanners because infant head scans may show degraded image quality, including non-uniformity and CT number shifts.
Product
Ingenuity Core Model Number 728321 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-0011-2017·2016-10-12
Philips Ingenuity Core 128 CT Scanner Recalled for Image Quality Defects
Philips Medical Systems is recalling 524 Ingenuity Core 128 CT scanners because high-resolution head scans may produce degraded image quality, including non-uniformity and CT number shifts.
Product
Ingenuity Core 128 Model Number 728323 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-0046-2017·2016-10-12
Toshiba Aquilion Lightning CT Scanner Recalled for Reconstruction Error
Toshiba is recalling 165 Aquilion Lightning 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 Aquilion Lightning TSX-035A CT Scanner.
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-2910-2016·2016-10-12
Integra Lumbar Drainage Set Recalled Due to Incomplete Packaging Seal
Integra LifeSciences Corp. is recalling specific lots of Lumbar Drainage Sets because final inspection revealed an incomplete packaging seal on the sterile product.
Product
Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch. One (1)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0037-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Orange Dental Porcelain
Ivoclar Vivadent is recalling 5 units of Zenostar MT Color Impulse orange dental porcelain due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0002-2017·2016-10-12
Ballester Hermanos Recalls Canned Octopus with Garlic Flavor Due to Mislabeling
Ballester Hermanos, Inc. is recalling 495 cases of Coloso brand canned octopus with garlic flavor in Puerto Rico because the product contains squid instead of octopus.
Product
Product in cans of 4 1/4 oz and 8 1/4 oz net weight. Label reading in part as: "Coloso***PULPO AL AJILLO***OCTOPUS WITH GARLIC FLAVOR***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-0031-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 19 units of Zenostar MT Color C2 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2915-2016·2016-10-12
New Star Lasers Recalls VariaBreeze Systems Due to Labeling Notification Failure
New Star Lasers is recalling 17 VariaBreeze laser systems because customers were not notified when promotional material was revised to remove outside-use indications.
Product
VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0029-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B4 Dental Porcelain Liquid
Ivoclar Vivadent is recalling 7 units of Zenostar MT Color B4 dental porcelain liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2911-2016·2016-10-12
Arrow Recalls Walrus Arterial Embolectomy Catheters Due to Labeling Errors
Arrow International Inc is recalling 2,425 Walrus Arterial Embolectomy Catheters nationwide due to incorrect labeling.
Product
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0020-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Violet Due to Packaging Leaks
Ivoclar Vivadent is recalling 25 units of Zenostar MT Color Impulse violet dental porcelain coloring due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0025-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A4 Dental Porcelain Liquid
Ivoclar Vivadent is recalling 11 units of Zenostar MT Color A4 dental porcelain liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0007-2017·2016-10-12
Sun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failures
Sun Pharmaceutical Industries is recalling 31,762 bottles of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications.
Product
BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0009-2017·2016-10-12
Philips Brilliance 64 CT Scanner Recalled for Infant Head Image Quality Issues
Philips Medical Systems is recalling 185 Brilliance 64 CT scanners because infant head scans in High Resolution mode may show degraded image quality.
Product
Brilliance 64 CT Model Number 728231 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