The Recall Desk

Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

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.

5451–5475 of 7443

  • CriticalFDA (Drugs)·D-1589-2014·2014-09-24

    American Health Packaging Recalls Mis-Labeled Ibuprofen Tablets

    American Health Packaging is recalling 137,300 Ibuprofen 600 mg tablets because some cartons were mis-labeled as Oxcarbazepine 300 mg.

    Product
    Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1597-2014·2014-09-24

    Nova Products Recalls Black Ant for Undeclared Sildenafil

    Nova Products, Inc. is voluntarily recalling Black Ant capsules because FDA analysis found undeclared sildenafil, an active ingredient in erectile dysfunction drugs.

    Product
    Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd, USA.,
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1598-2014·2014-09-24

    XZEN GOLD Recalled for Undeclared Erectile Dysfunction Drug Ingredients

    Nova Products, Inc. is voluntarily recalling XZEN GOLD capsules because FDA testing found undeclared sildenafil and tadalafil.

    Product
    XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1600-2014·2014-09-24

    Nova Products Recalls Xzen 1200 Due to Undeclared Erectile Dysfunction Ingredients

    Nova Products, Inc. is voluntarily recalling Xzen 1200 capsules because FDA analysis found undeclared sildenafil and tadalafil, active ingredients in erectile dysfunction drugs.

    Product
    Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2437-2014·2014-09-24

    Vibrant Health Recalls Rainbow Vibrance Superfood Due to Salmonella Risk

    Vibrant Health is recalling Rainbow Vibrance Hi ORAC Superfood because a raw material used in its manufacture was found to contain Salmonella bacteria.

    Product
    Rainbow Vibrance Hi ORAC Superfood, 177g, 6.24 oz. Product Code: RV
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2435-2014·2014-09-24

    Vibrant Health Recalls Green Vibrance 15 Due to Salmonella Contamination

    Vibrant Health is recalling Green Vibrance 15 dietary supplements because a raw material used in manufacturing was found to contain Salmonella bacteria.

    Product
    Green Vibrance 15 single serve pkts, 181.5g, 6.4oz. Product Code: GVSD
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1599-2014·2014-09-24

    XZEN Platinum Recalled for Undeclared Erectile Dysfunction Drug Ingredients

    Nova Products, Inc. is voluntarily recalling XZEN Platinum capsules because FDA analysis found undeclared sildenafil and tadalafil.

    Product
    XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los Angeles, CA 90012
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2438-2014·2014-09-24

    Swanson Organic Carob Powder Recalled for Potential Salmonella Risk

    Swanson Health Products is recalling 544 containers of 1 lb Certified Organic Carob Powder due to a potential risk of Salmonella contamination from a raw ingredient.

    Product
    Swanson 100% Certified Organic, Carob Powder, Raw Chocolate Substitute, Net wt 1 lb (454 grams), in round 1000 cc High Density Poly-ethylene plastic containers, Product of Italy, Distributed by Swanson Health Products, PO Box 2803, Fargo ND 58108 USA, SWF115.
    Category
    Food
    Distribution
    39 states
  • CriticalFDA (Drugs)·D-1591-2014·2014-09-24

    Baxter Recalls Sodium Chloride Injection Bags Due to Particulate Matter

    Baxter Healthcare is recalling specific lots of 0.9% Sodium Chloride Injection USP bags due to the presence of particulate matter, including fibers and plastics.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1594-2014·2014-09-24

    Dietary Supplement Recalled for Undeclared Sibutramine and Lack of Approval

    Nature's Universe is recalling ThinoGenics dietary supplements because they contain undeclared sibutramine and were marketed without FDA approval.

    Product
    THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1603-2014·2014-09-24

    Nova Products Recalls Mojo Risen Due to Undeclared Sildenafil

    Nova Products, Inc. is voluntarily recalling Mojo Risen because FDA testing found undeclared sildenafil, an active ingredient in erectile dysfunction drugs.

    Product
    MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2422-2014·2014-09-17

    YF Brand Sesame Cracker Recalled for Undeclared Peanuts

    Domega NY International Co Ltd is recalling YF brand Sesame Crackers because they contain undeclared peanuts. The product was sold in the New York City area.

    Product
    YF brand CRACKER (SESAME), Net Wt. 14 oz. (400g), UPC 6 920580 733416 --- The product is packed in a plastic package.
    Category
    Food
    Distribution
    1 state
  • CriticalUSDA FSIS·058-2014·2014-09-12

    Claude's Beef Jerky Recalled for Undeclared Allergens and Lack of Inspection

    Jerky By Art is recalling Claude's Beef Jerky with Red Chile because it was produced without USDA inspection and contains undeclared wheat and anchovies.

    Product
    New Mexico Firm Recalls Beef Jerky Products Produced Without the Benefit of Inspection and Misbranded With Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2427-2014·2014-09-10

    Customed Recalls O.B. Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling O.B. Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE LIF ( I) VAGINAL PACKING SPONGEXRD ( I) BOWL WITH LID PLASTIC 80oz ( I) RECEIVING BLANKET 100% COTTON (I) BABY BLANKET POLY AB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2360-2014·2014-09-10

    Customed Recalls C-Section Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling C-Section surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BABY BLANKET PRINTED (1 0) LAP SPONGES PREWASH 18" X 18" XRD (1) BOWL PLASTIC WITH LID 80oz. (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2504-2014·2014-09-10

    Customed Recalls Neuro Spine Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Neuro Spine Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W' X 6" (I) CAUTERY PENCIL HAND SWITCHING LIF (4) UTILITY DRAPE W/TAPE L/F (I)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2302-2014·2014-09-10

    Customed Angiodrape Pack Recalled for Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,536 units of Angiodrape Packs due to potential packaging integrity issues that could compromise sterility and risk patient injury.

    Product
    Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,towel clamp,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2471-2014·2014-09-10

    Customed Recalls EENT Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling EENT surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    EENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL (1) SHEET ENT SPLIT 110" X 77" SMS (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE HEAD W!TAPE 44" X 26" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2456-2014·2014-09-10

    Customed Recalls Extremity Arm Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 112 units of Extremity Arm Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRAP 6" X 5yds (3) BANDAGE ELASTIC 4" X 5yds (1) BANDAGE ESMARK 6" X 9 (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECTX 12' (1) SK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2498-2014·2014-09-10

    Customed Recalls Endovascular Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Endovascular Packs (code 900-2715) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF (2) TOWELS ABSORBENT 15 X 20 LIF ( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf (2) BAG BAND FLUOROSCOPE 36 X 30 LIF ( I) NEEDLE HYPODERMIC 21G X I Y, LIF (2) GOWN LARGE SMS IMPE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2484-2014·2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

    Customed is recalling specific lots of HIP PACK I surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) MAYO STAND COVER REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 12" X 48" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE HIP 89" X 128" REINFORCE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2321-2014·2014-09-10

    Customed Recalls Major Lap Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Major Lap Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE (2) L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2356-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 273 units of arthroscopy packs across 11 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd. UF (1) IMPERVIOUS STOCKINETTE 14" X 48" (1) HUCK CLOTH TOWEL WHITE (1) MAYO STAND COVER REINFORCED LIF (1) U DRAPE 60" X70" WITH TAPE SPLIT (4) STR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2422-2014·2014-09-10

    Customed Recalls Endoveneous Custom Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 12 lots of Endoveneous Custom Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (3) GOWN SMS X-LARGE STD NON REINFORCED ( 1) TABLE COVER 44" X 90" (4) DRAP
    Category
    Medical Device
    Distribution
    Distributed nationwide