Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

26–50 of 261

LowFDA (Food)·H-0569-2026·2026-03-25
Multivitamin with Fluoride Chewable Tablets Recalled for Subpotent Vitamin D
Winder Laboratories is recalling Multivitamin with Fluoride Chewable Tablets Grape Flavor because the product contains subpotent Vitamin D levels. The FDA discovered this deficiency during an inspection.
Product
Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; NDC 75826-171-10 1mg 100 TABLETS UPC 3 15826 17110 5 Manufactured by: WINDER LABORATORIES LLC Winder, GA 30680
Category
Drug
Distribution
25 states
LowFDA (Food)·H-0545-2026·2026-03-18
C2O Coconut Water with Pulp 15-pack with incorrect outer box labels
The outer cardboard box of C2O Coconut Water with Pulp (17.5 oz) 15-packs contains incorrect Nutrition Facts and Ingredient Lists that fail to disclose 5g of added sugar per can, although the can itself has correct labeling.
Product
C2O Coconut Water with Pulp (17.5 oz) 15 Pack UPC: 8-50274-00792-8
Category
Food
Distribution
11 states
LowFDA (Devices)·Z-1505-2026·2026-03-18
Penner Pacific Bathing Spa units lack required unique device identifier
Penner Patient Care recalled 25 units of Penner Pacific Bathing Spa models 390010-1, 390010-X, and 390010-2 due to missing unique device identifiers.
Product
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1502-2026·2026-03-18
Penner Pacific Bathing Spa recalled for missing unique device identifier
Penner Patient Care, Inc. is recalling 45 units of the Penner Pacific Bathing Spa (Model 360020-1P) distributed nationwide due to missing unique device identifiers (UDI).
Product
Penner Pacific Bathing Spa, Model Numbers 360020-1P
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1501-2026·2026-03-18
Penner Pacific Bathing Spa recalled for missing unique device identifier
Penner Patient Care is recalling the Penner Pacific Bathing Spa, Model 360020-1EP due to a missing unique device identifier.
Product
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1507-2026·2026-03-18
Penner Pacific Bathing Spa Recalled for Missing Device Identifier
Penner Patient Care is recalling 190 Penner Pacific Bathing Spa units (models 760010-1 and 770010-1) because they do not bear the required unique device identifier.
Product
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1506-2026·2026-03-18
Penner Pacific Bathing Spa recalled for missing unique device identifier
Penner Patient Care, Inc. is recalling Penner Pacific Bathing Spa units because the devices do not bear a unique device identifier.
Product
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1504-2026·2026-03-18
Penner Pacific Bathing Spa units recalled due to missing device identifier
Penner Patient Care is recalling 158 units of Penner Pacific Bathing Spa devices nationwide. The devices lack the required unique device identifier designation.
Product
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1503-2026·2026-03-18
Penner Pacific Bathing Spa recalled for missing unique device identifier
Penner Patient Care is recalling 206 units of Penner Pacific Bathing Spa because the devices do not bear a unique device identifier (UDI) on their labeling.
Product
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1508-2026·2026-03-18
Penner Pacific Bathing Spa Recalled for Missing Device Identifier
Penner Patient Care is recalling 26 units of the Penner Pacific Bathing Spa Model 860010-1L because the device lacks a required unique device identifier. The product was distributed nationwide.
Product
Penner Pacific Bathing Spa, Model Numbers 860010-1L
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1500-2026·2026-03-18
Penner Pacific Bathing Spa Recalled for Missing Device Identifier
Penner Patient Care, Inc. is recalling Penner Pacific Bathing Spa units nationwide because they lack a unique device identifier required by FDA regulations. The recall affects 643 units.
Product
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0381-2026·2026-03-11
Nilotinib Capsules Recalled Due to Failed Tablet/Capsule Specifications
Cipla USA, Inc. is recalling Nilotinib 150 mg capsules nationwide due to failed tablet/capsule specifications discovered during 6-month stability testing. The product's visual appearance and description did not meet established quality standards.
Product
NILOTINIB — NILOTINIB (NILOTINIB)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0382-2026·2026-03-11
Nilotinib Capsules Recalled Due to Failed Specifications
Cipla USA recalls Nilotinib 200 mg capsules (Lot 5GJ0223) nationwide due to failed appearance and description specifications in stability testing.
Product
NILOTINIB — NILOTINIB (NILOTINIB)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1358-2026·2026-02-18
FDA Recalls Surepulse Newborn Heart Rate Monitor Cap for Labeling Error
Surepulse Medical is recalling certain newborn heart rate monitor caps due to incorrect sizing information in the labeling. The issue affects specific lot numbers distributed in the US and internationally.
Product
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1337-2026·2026-02-18
Straumann Impression Post Closed Tray Recalled for Color Mismatch in Packaging
Straumann USA is recalling 561 units of WB Impression Post Closed Tray due to incorrect impression caps in packaging. The caps are magenta instead of the intended brown color.
Product
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1356-2026·2026-02-18
Surepulse Newborn Heart Rate Monitor Cap Recalled for Incorrect Sizing Label
Surepulse Medical recalled the VS Cap Extra Small component of its newborn heart rate monitor due to an incorrect sizing guide in the product labeling.
Product
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Food)·H-0442-2026·2026-02-11
OptiWize Collagen Plus Supplement Recalled for Labeling Discrepancy
OptiWize Inc. is recalling OptiWize Collagen Plus supplements after NSF testing found that the manganese level did not match what was stated on the label.
Product
OptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.
Category
Food
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0297-2026·2026-02-04
Mouthwash Recall: Missing or Illegible Lot and Expiration Date Coding
Haleon is recalling Parodontax mouthwash due to missing or illegible lot and expiration date coding on bottles. Approximately 84,764 bottles were distributed nationwide.
Product
PARODONTAX — PARODONTAX (CETYLPYRIDINIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1030-2026·2026-01-14
Impella 5.5 Cardiac Assist Devices Recalled for Incorrect Outer Box Packaging
Abiomed is recalling six Impella 5.5 with SmartAssist S2 cardiac assist devices distributed to Australia and Taiwan because they were packaged in an incorrect outer box carton.
Product
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-0247-2026·2026-01-07
Trazodone Hydrochloride tablets recalled for physical manufacturing defect
Zydus Pharmaceuticals is recalling Trazodone Hydrochloride 100mg tablets due to some tablets having a dent on the surface. No illnesses have been reported.
Product
TRAZODONE HYDROCHLORIDE — TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0932-2026·2025-12-24
Cardiosave Rescue Recalled for Instructions for Use Standards Update
Datascope Corp. is recalling the Cardiosave Rescue. An addendum to the Instructions for Use corrects the reference standards for vibration and shock.
Product
Cardiosave Rescue
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0931-2026·2025-12-24
Cardiosave Hybrid cardiac device instructions corrected for standards references
Datascope Corp. is updating the Instructions for Use for the Cardiosave Hybrid to correct standards references in the Vibration and Shock Table. Approximately 11,470 units have been distributed in the US and internationally.
Product
Cardiosave Hybrid
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0895-2026·2025-12-17
Forza Ti Spacer System Recalled for Labeling Inconsistencies
Orthofix U.S. LLC is recalling 14,201 units of the Forza Ti Spacer System, a spinal fusion device, due to labeling inconsistencies where claims are not consistently present across affected units.
Product
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP F
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0223-2026·2025-12-17
Morphine sulfate oral solution recalled due to carton label size mismatch
Winder Laboratories is recalling 3,528 bottles of morphine sulfate oral solution because the carton label states an incorrect bottle size that does not match the actual bottle inside.
Product
MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0892-2026·2025-12-17
FDA Recalls FORZA PTC Spacer System for Labeling Inconsistencies
Orthofix U.S. LLC is recalling the FORZA PTC Spacer System due to labeling that contains claims not consistently presented across product materials. The recall affects multiple device models.
Product
Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H; 38-1010
Category
Medical Device
Distribution
Distributed nationwide