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.

12476–12500 of 21617

ModerateFDA (Devices)·Z-2540-2017·2017-06-21
Cook Inc. Recalls Vue Optic Endoscopes Due to Insufficient Reprocessing Instructions
Cook Inc. is voluntarily recalling Vue Optic Visualization Sources and Flexor Vue Deflecting Endoscopic Systems because current reprocessing instructions lack sufficient detail for cleaning and sterilization.
Product
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
Category
Medical Device
Distribution
6 states
ModerateFDA (Drugs)·D-0908-2017·2017-06-21
Pharmedium Recalls Potassium Phosphate Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 144 bags of Potassium Phosphate in 0.5% Dextrose because the product label incorrectly states a volume of 150 mL instead of the actual 100 mL.
Product
Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2430-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards due to potential container integrity issues that may expose the product to moisture and cause antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN82), REF 413439, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2559-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Nail Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary nail implants and accessories because packaging design verification tests failed.
Product
Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2427-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN79), REF 413436, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2419-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN70), REF 413401, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2468-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N293), REF 415369, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2361-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-GP69), REF 22304, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2342-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram-Positive Identification Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram-Positive identification cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2483-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Container Integrity
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised containers may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-GP76), IVD, REF 418424, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2521-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N357), IVD, REF 421451, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2582-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Rod Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary rod implants and accessories because packaging design verification tests failed. The recall affects 9,867 units distributed worldwide.
Product
Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2362-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2489-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N323), IVD, REF 418602, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2487-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P640), IVD, REF 418579, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2584-2017·2017-06-21
Acumedia Recalls Palcam Supplement Due to Possible Bacillus Contamination
Acumedia Manufacturers, Inc. is recalling Palcam Supplement (PN 7987) due to possible contamination with Bacillus spp. The product is used for Listeria enrichment.
Product
Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2425-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may allow moisture exposure, leading to antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN76), REF 413433, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2549-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Femoral Stems Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary femoral stems and accessories due to packaging design verification test failures.
Product
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2418-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2428-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2437-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-P625), REF 413727, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2522-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N359), IVD, REF 421573, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2470-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P634), IVD, REF 415671, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2451-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N279), REF 414492, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2389-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N203), REF 412864, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide