United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: L...
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118...
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330...
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 0...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Newmar Corporation - Incorrect Cargo Carrying Capacity on Label/FMVSS 120
Incorrect weight information can allow the vehicle to be overloaded, increasing the risk of a crash.
The product is a handheld ultraviolet-C germicidal wand and contains two low-pre...
In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM ...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Roadtrek Inc. - Pop-Top Latch and Safety Straps May Fail
A pop-top that lifts during transit can distract the driver, or detach if the secondary safety straps fail, increasing the risk of a crash.
Newmar Corporation - Front Chin Spoiler May Detach During Transit
A detached spoiler may become a road hazard, increasing the risk of a crash.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Bombay Kitchen brand Punjabi Mix; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour...
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRA...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 F...
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
The product is a handheld ultraviolet-C germicidal wand and contains a combinati...
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx ...
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Numb...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.