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.

5476–5500 of 7443

CriticalFDA (Devices)·Z-2340-2014·2014-09-10
Customed Fanfold Drapes Recalled for Potential Packaging Integrity Compromise
Customed, Inc. is recalling Fanfold Drapes due to potential packaging integrity issues that could compromise sterility and risk patient injury.
Product
FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2453-2014·2014-09-10
Customed Recalls Vaginal Procedure Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling vaginal procedure packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (1) COVER TABLE REINF 50" X 90" LIF (1) TUBE SUC
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2412-2014·2014-09-10
Puratos Dark Organic Chocolate Chips Recalled for Milk Allergen
Puratos Chocolate USA is recalling 22,000 lbs of Dark Organic 1M Chip chocolate due to a reported allergic reaction to milk protein.
Product
Puratos Chocolante, Dark Organic 1M Chip, Item Number 0065064002SH11, Net Weight: 25 lbs.
Category
Food
Distribution
2 states
CriticalFDA (Devices)·Z-2346-2014·2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,041 units of EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON NEUTR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2304-2014·2014-09-10
Customed Laparoscopy Convenience Packs Recalled for Packaging Integrity Concerns
Customed, Inc. is recalling 30 lots of EO sterilized laparoscopy convenience packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.
Product
Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. EO steriliz
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2529-2014·2014-09-10
Customed Recalls EO Sterilized Surgical Gowns Due to Packaging Integrity Concerns
Customed, Inc. is recalling EO sterilized surgical gowns because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2320-2014·2014-09-10
Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 30 lots of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 (1) BLANKET BABY 30" X 30" POLY ABS IMP (1) BOWL UTILITY QUART 32oz. (1) TUBE FEEDING 8Fr. 15" LONG (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR (1) BEANNIES BABY (2) PAD OBSTRETICAL XLGE ST.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2500-2014·2014-09-10
Customed Recalls Shoulder Arthroscopy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 74 units of Shoulder Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2481-2014·2014-09-10
Customed Recalls Shoulder Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 114 units of Shoulder Packs (Code 900-2616) because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.
Product
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2381-2014·2014-09-10
Customed Recalls Premium Ophthalmic Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 720 units of Premium Ophthalmic Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPONGE EYE SPEAR MICRO (1) SHIELD EYE UNIVERSAL (6) COTTON TIP APPLICATION 6" WOOD LIF (1 0) GAUZE SPONGES 4"X 4" 12PL Y (2) TOWELS ABSORBENT
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2391-2014·2014-09-10
Customed Recalls Plastic Surgery Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling plastic surgery packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF (10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90" (1) DRAPE SHEET 70" X 100" LIF (2) SURGICAL BLADE #15 S/STEEL (1) DRAPE HEAD WIT APE 44" X 26"
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2446-2014·2014-09-10
Customed Recalls Central Line Full Body Drapes Due to Packaging Integrity Concerns
Customed, Inc. is recalling Central Line Full Body Drapes because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20" (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41" X 58" SMS (1) DRAPE BRACHIAL AN
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2486-2014·2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling specific lots of EO-sterilized surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS TAPE 24" X 4" (1) SUTURE BAG FLORAL (1) SHEET SPLIT W/ADHESIVE 1 08" X 77"
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2309-2014·2014-09-10
Customed Recalls Labor and Delivery Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 3,448 units of Labor and Delivery Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 20" LIF (1) BABY BLANKET PRINTED LIF (2) PAD OBSTETRICAL XLGE LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) BABY BLANKET POLY ABS. IMP. LIF (1) Pr
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2060-2014·2014-09-10
Lacteos Santa Martha Fresh Curd Recalled for Listeria Contamination
Oasis Brands is recalling Lacteos Santa Martha Fresh Curd because a state sample tested positive for Listeria monocytogenes.
Product
Lacteos Santa Martha Quesito Casero Fresh Curd Net Weight 12oz Distributed by Oasis Brands Inc., Miami FL 33192
Category
Food
Distribution
5 states
CriticalFDA (Devices)·Z-2533-2014·2014-09-10
Customed Recalls Laparoscopy Colorectal Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STA
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2414-2014·2014-09-10
Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 39 lots of arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT. X" X 12' (1) STOCKINETTE IMPERVIOUS 14" X 4
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1562-2014·2014-09-03
Central Admixture Pharmacy Recalls Contaminated Low Potassium Cardioplegia
Central Admixture Pharmacy Services is recalling Low Potassium Cardioplegia doses due to non-sterility and Aspergillus contamination.
Product
LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Category
Drug
Distribution
2 states
CriticalFDA (Drugs)·D-1561-2014·2014-09-03
Adenosine Injection Recalled for Microbial Contamination
Central Admixture Pharmacy Services is recalling adenosine 90 mg injections in Michigan and Wisconsin due to Aspergillus species contamination.
Product
adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Category
Drug
Distribution
2 states
CriticalFDA (Food)·F-2397-2014·2014-09-03
McCormick Ground Oregano Recalled Due to Salmonella Contamination
McCormick & Company is recalling specific bottles of ground oregano because a retail sample tested positive for Salmonella. Consumers should check their pantries for the affected product codes.
Product
McCormick Ground Oregano in 0.75 oz plastic bottle. UPC NUMBER: 52100003566 (as seen on label: 0-523561-6) MCCORMICK ITEM NUMBER: 900356
Category
Food
Distribution
39 states
CriticalFDA (Drugs)·D-1568-2014·2014-09-03
Pharmakon Recalls Atropine Sulfate Syringes Due to Undeclared Benzyl Alcohol
Pharmakon Pharmaceuticals is recalling specific lots of Atropine Sulfate Injection because they contain undeclared benzyl alcohol.
Product
Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.
Category
Drug
Distribution
4 states
CriticalFDA (Food)·F-2392-2014·2014-09-03
Health Matters America Recalls Organic Traditions Sprouted Chia Seed Powder
Health Matters America Inc. is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder due to possible Salmonella contamination.
Product
ORGANIC TRADITIONS SPROUTED CHIA SEED POWDER NET WT. 8 oz. and 16 oz., UPC 854260006162, item number AHM616 and UPC 854260005462, item number AHM546
Category
Food
Distribution
25 states
CriticalFDA (Drugs)·D-1563-2014·2014-09-03
Abrams Royal Pharmacy Recalls Non-Sterile Mineral IV Injection
Abrams Royal Pharmacy is recalling 74 units of Mineral IV Injection found to contain Sphingomonas paucimobilis, indicating non-sterility.
Product
MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2386-2014·2014-09-03
Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination
Tiny Isle Chocolate Truffles Spicy Lava are being recalled due to potential Salmonella contamination in the carob powder used.
Product
Tiny Isle Chocolate Truffles Spicy Lava: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
Category
Food
Distribution
1 state
CriticalFDA (Food)·F-2382-2014·2014-09-03
Tiny Isle Mac Nut Fudge Recalled for Potential Salmonella Contamination
Florimont, Inc. is recalling Tiny Isle Mac Nut Fudge because the carob powder used in the product is under recall for potential Salmonella contamination.
Product
Tiny Isle Mac Nut Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil, agave nectar, carob powder,mac nuts, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
Category
Food
Distribution
1 state