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.
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Becton Dickinson is recalling 890 PrepStain Tecan US-II instruments because a rack setting was incorrectly entered during routine maintenance.
SpineNet is recalling 100 units of Bone Marrow Aspiration Needle Kits because they were marketed for use with the SpineNet ACC device without FDA clearance or approval.
Fresenius Medical Care is recalling 132 MeDS pumps used to administer Venofer during hemodialysis because the device may not meet dosage accuracy requirements.
Life Technologies is recalling 15 kits of HSV-2 Primers because they failed to amplify HSV-2 DNA. The products were distributed in Delaware, Iowa, Minnesota, and North Carolina.
Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.
Waldemar Link is recalling four trial stems for a reconstruction prosthesis because they were manufactured using the wrong design.
Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.
Stryker is recalling 23 units of Asnis III Cannulated Screws because the length of the device was reported to be incorrect.
Micro Therapeutics Inc is recalling 62 Pipeline Embolization Devices because the instructions for use are missing specific contraindications regarding pre-existing stents and medication designations.
Ventana Medical Systems is recalling BenchMark and Discovery instruments because a heating element may separate, causing inconsistent staining without an error message.
Custom Co-Pak is recalling Long Life Premium Organic Green Tea with Lemongrass due to possible contamination in the lemongrass ingredient.
3M ESPE is recalling Unitek Primary Stainless Steel Crowns because they were manufactured with the incorrect marginal contour edge.
Becton Dickinson is recalling 890 PrepStain Tecan US-I instruments because a rack setting was incorrectly entered during routine maintenance.
Ann's House of Nuts is recalling Daily Chef Tropical Fruit & Nut Blend because it contains undeclared Yellow #5 and #6 dyes.
Siemens Healthcare Diagnostics is recalling PSA Assay kits for use in IMMULITE systems due to a confirmed positive bias of 20% to 23% in patient results.
Sarken, Inc. is recalling STAT! Multi-Drug Test Panels because they were distributed without adequate labeling and instructions for use, which could lead to misuse and incorrect test results.
Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.
Synthes USA HQ, Inc. is recalling 11 units of 2.4 mm VA-LCP distal radius plates that may be incorrectly etched with 'R' instead of 'L'.
Synthes USA HQ, Inc. is recalling Trauma Nail Systems because the outer packaging pouch may be compromised, potentially affecting the sterile internal pouch.
Actavis South Atlantic LLC is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets (XL) 300 mg because they failed to meet dissolution specifications.
Waldemar Link is recalling five trial stems for a reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Siemens is recalling Dimension Vista 500 and 1500 systems due to a rare software issue that may cause samples to be dispensed into previously used wells.
Custom Co-Pak is recalling Garbanzo Iced Lemon Grass Ginger Tea due to possible contamination by the lemongrass supplier.
SpineNet is recalling 400 anterior cervical cages because the instructions for use contained statements that should have been removed prior to marketing.