Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
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.
Stradis Healthcare is recalling Standard Packs containing Devon Light Gloves because the glove component was recalled by Medtronic.
Stradis Healthcare is recalling Hand Packs containing Devon Light Gloves due to a manufacturer recall of the glove component by Medtronic.
Stradis Healthcare is recalling Face Neck Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
Integra LifeSciences is voluntarily recalling 123 Tuohy needles because they were incorrectly labeled as 18 gauge, 3.5 inch instead of 20 gauge, 5 inch.
Gourmet Culinary Solutions is recalling approximately 495 pounds of turkey sausage products that may contain pieces of a conveyor belt.
Roche Diagnostics is recalling 6,255 units of Triglycerides/Glycerol Blanked in vitro test kits due to possible drug interference that may cause falsely decreased results.
Roche is recalling Triglycerides GPO tests because certain drugs may cause falsely decreased results on specific Cobas analyzers.
Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Siemens Medical Solutions USA is recalling 573 ACUSON SC2000 ultrasound systems because specific keystrokes during 2D Stress Echo studies may cause selected clips to not be saved.
Siemens is recalling 40 SOMATOM Emotion 16 CT scanners due to broken or bowed screws in the gantry balance weight assembly.
Siemens Healthcare Diagnostics is recalling 1,355 units of the EasyLink Data Management System due to software issues affecting reference ranges and sample actions.
The FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Tecan US, Inc. is recalling 868 Infinite M1000 PRO microplate readers because a firmware bug causes incorrect luminescence values to be displayed.
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Intuitive Surgical is recalling da Vinci Xi Instrument Arm Drapes because a pinched drape may cause a 'Missing reload error' on the Vision Cart touchscreen.
Roche Diagnostics is recalling 6,255 units of the LDL-Cholesterol plus gen.2. test due to potential false results caused by drug interference.
Siemens recalls CentraLink software because the sample query function may fail to return all samples from Dimension Vista systems under specific configurations.
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Roche Diagnostics is recalling the LDL-Cholesterol gen.2 test because certain drugs may cause falsely decreased results when using the Trinder reaction method.
Synthes, Inc. is recalling 276 DePuy Synthes 6.5 mm Titanium Recon Screws because certain lots contain the wrong insert.
RTI Surgical is recalling 18 units of three lots of Bullet-Tip PEEK VBR implants distributed in Florida and New York due to incorrect color labeling.
Axis-Shield Diagnostics is recalling Liquid Stable 2-Part Homocysteine Reagents due to performance deterioration that causes under-recovery of test results.
Covidien LLC is recalling Palindrome SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Roche Diagnostics is recalling Cholesterol CHOD-PAP reagents because drug interference may cause falsely decreased test results.
Vascutek, Ltd. is recalling 12 Gelseal vascular grafts labeled as 30cm but actually 15cm. The devices were distributed in Michigan and four other countries.