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.
ROi CPS LLC recalled surgical convenience kits because they contained 3M surgical drapes that were recalled. The specific defect is not described.
ROi CPS LLC is recalling Regard hip arthroscopy surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The kits were distributed in LA, MO, NC, and FL.
Beckman Coulter is recalling MicroScan autoSCAN-4 Instruments due to manufacturing with an incorrect diffuser plate component. Affected units were distributed worldwide including multiple U.S. states and countries.
ROi CPS LLC is recalling 258 surgical convenience kits containing 3M surgical drapes that were subject to a subsequent recall. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 228 gastric surgery convenience kits because they contained 3M surgical drapes that were subsequently recalled. The affected kits were distributed in LA, MO, NC, and FL.
Surgical convenience kits containing 3M surgical drapes that were subsequently recalled have been pulled from distribution in LA, MO, NC, and FL. Affected lot numbers are 91465 (exp 2/7/2024) and 92444 (exp 5/5/2024).
ROi CPS LLC is recalling 188 regard SPINE PACK surgical convenience kits that contain 3M surgical drapes subject to a separate FDA recall. The affected lots should be removed from use.
Orthopaedic surgical convenience kits distributed in four states contained 3M surgical drapes that were subsequently recalled. ROi CPS LLC is recalling 38 affected kits.
Endo-Therapeutics is recalling 28 eSuction Small Cavity Model ET2005 devices distributed in Florida and Pennsylvania due to improper regulatory classification.
Sun Pharmaceutical recalls Pantoprazole Sodium oral suspension nationwide due to product discoloration. Lot MHC1317A with approximately 14,064 units was distributed in the USA.
ROi CPS LLC is recalling 190 units of regard BASIC NEURO surgical convenience kits distributed in LA, MO, NC, and FL. The kits contained 3M surgical drapes that were subsequently recalled.
Cataract eye surgery convenience kits containing recalled 3M surgical drapes were distributed to four states. ROi CPS LLC has recalled 780 units of the regard CATARACT product.
Orthopedic surgical convenience kits distributed in four states were recalled because they contain 3M surgical drapes that were subject to a separate recall.
Surgical convenience kits are being recalled because they contain 3M surgical drapes that were previously recalled. A total of 164 units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 166 Regard Pediatric Urology surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contained 3M surgical drapes that were subject to a separate recall.
ROi CPS LLC is recalling 108 surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida that contained 3M surgical drapes which were subsequently recalled.
Visionsense, Ltd. issued a voluntary Class II recall of the VS3 Iridium infrared fluorescence microscope affecting 34 units with US Nationwide distribution.
Winnebago is recalling certain 2021-2022 travel trailers because cabinet door and drawer handles may have sharp edges. Dealers will replace the handles free of charge.
Sonendo Inc is recalling 15 GentleWave System APM Procedure Instruments (Model GW-APM-PI02) due to erroneous unit carton labels. The instruments were distributed worldwide, including Ohio and Canada.
Nephron Sterile Compounding Center is recalling 56,220 vials of PF-Neostigmine Methylsulfate Injection due to potential cross-contamination from manufacturing control deviations.
Abbott Laboratories is recalling specific lots of Similac Water due to compromised seal integrity that could lead to spoilage. The recall affects 14,588,544 bottles distributed across the US, territories, and international locations.
Atrium Medical Corporation is recalling Atrium Ocean Wet Suction Water Seal Chest Drains (Product Code 2002-000) distributed in the United States due to warehouse temperature excursions in July and August 2021. No patient harm has been reported.
Abbott Laboratories is recalling batches of Similac 360 Total Care and Total Care Sensitive infant formula 2 fl oz discharge kits for compromised seal integrity that could allow spoilage. The affected batch is identified by product code 39480N200 with a Best By date of 04/01/23.
Aadi Bioscience recalls 2,333 vials of Fyarro (sirolimus) injectable suspension distributed to four U.S. states due to failed stability specifications. No illnesses or injuries have been reported.
Sonendo Inc is recalling 16 GentleWave System Posterior CleanFlow procedure instruments with lot number W2022080204R due to erroneous unit carton labels that could affect proper identification and use.