The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

25026–25050 of 32194

  • SevereFDA (Devices)·Z-2509-2014·2014-09-10

    Customed Recalls Orthopedic Implant Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 180 units of Orthopedic Implant Packs (Code 900-2903) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER (1) BAG SUTURE FLORAL (1) U - DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TUBE SUCTION CONNECT W' X 12' UF (2) PAD ABDOMINAL 8" X 7.5" (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2371-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 512 units of arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6" X 5yrd. LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) DURAPREP SURGICAL SOLUTION 26m I LIF (1) STOCKINETIE IMPERVIOUS (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) SHEET ARTHROSCOPY T STD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2396-2014·2014-09-10

    Customed Recalls Angiography Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 570 units of angiography packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2423-2014·2014-09-10

    Customed Recalls HIGADO & PANCREA PACK Due to Packaging Integrity Concerns

    Customed, Inc. is recalling HIGADO & PANCREA PACK surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE WITHOUT VENT (4) DRAPE UTILITY WITH TAPE (6) TOWELS CLOTH HUCK BLUE (1) SHEET DRAPE 41 " X 58" SMS (1) MAYO TRAY LARGE (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE INCISE ANTIMICROBIAL 23" X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2407-2014·2014-09-10

    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) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (2) LEGGINS W/7'' CUFF 30" X 42" (1) GOWN LARGE SMS IMPERVIOUS REINFORCED (3) TOWELS ABSORBENT 15" X 20" LIF (I) PAD OBSTETRICAL X-LARGE ST. (I) PACKING VAG JNAL 4" X 36" 8PL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2513-2014·2014-09-10

    Customed Recalls Obstetrical Surgical Packs Due to Potential Packaging Integrity Issues

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

    Product
    Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100 COTTON (3) TOWEL ABSORBENT 15 X 20 LIF (10) GAUZE SPONGE 4 X 4 16PLY XRD LIF (1) SYRINGE EAR/ULCER 2oz. LIF (1) DRAPE ABDOMINAL WITH TAPE 40X54 LIF (2) LEGGINS W/7'' CUFF 30X42 L/F (1) GOWN XL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2388-2014·2014-09-10

    Customed Recalls Pediatric Lap Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 984 units of Pediatric Lap Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAND COVER REINFORCED LIF ( I) TABLE COVER REINFORCED 50" X 90" LIF (2) DRAPE SHEET 41 " X 58" SMS (2) TOWELS ABSORBENT 15" x 20" LIF (I ) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE L/F EO…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2399-2014·2014-09-10

    Customed Recalls Laparoscopy Cholecystectomy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 148 units of laparoscopy cholecystectomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF (2) ABSORBENT TOWELS 15" X 20" UF (1) MAYO STAND COVER REINFORCED UF (4) BANDAGE ADHESIVE W' x 3" L I F (4) DRAPE UTILITY WIT APE UF (1) TUBE SUCTION CONNECT. Y..'' X 12' UF (1) INSUFLAT TUBING…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2390-2014·2014-09-10

    Customed Recalls VEIN PACK Surgical Kits Due to Packaging Integrity Concerns

    Customed, Inc. is recalling specific lots of VEIN PACK surgical kits because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1) EXTREMITY SHEET ABS LIF (1) WRAPPER 36" X 36" (1) IMP. STOCKINETTE 14" X 48" LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2575-2014·2014-09-10

    Zimmer Persona Knee Trial Articular Surface Provisional Breakage Recall

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.

    Product
    PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2350-2014·2014-09-10

    Customed Recalls Neuro Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 37 lots of NEURO PACK surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    NEURO PACK- (1)TABLE COVER 44" x 90" (1) GOWN SURGEON REINFORCED X-LARGE TIWRAP (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) BAG SUTURE FLORAL (1) MAYO STAND COVER REINFORCED LIF (2) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (1) U-DRAPE 60" X 70"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2344-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 20 lots of arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BLADE SURGICAL # 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1 ~ LIF (1) TUR Y SET…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2372-2014·2014-09-10

    Customed Recalls Pery Gyn Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF (1) TOWEL ABSORBENT 15" X 20" UF (2) LEGGINGS W/7" CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" UF (1) DRAPE UNDERBUTTOCK WITH POUCH EO sterilized surgical convenient packs packaged into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2448-2014·2014-09-10

    Customed Recalls Lumbar Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 280 units of Lumbar Packs for Advanced Ambulatory Surgical Centers because packaging integrity may be compromised, risking loss of sterility.

    Product
    LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" UF (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) STRIP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2483-2014·2014-09-10

    Customed recalls surgical drapes due to potential packaging integrity issues

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

    Product
    LAP Abdom w/pouch Customed code 900-2619, contains: (1) DRAPE LAP. ABDOM W/POUCH 102" X 122" X 78" (1) WRAPPER 30" X 30" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2435-2014·2014-09-10

    Customed Recalls Knee Arthroscopy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 22 lots of Knee Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    KNEE ARTHROSCOPY PACK CONTENTS: (1) TOWEL ABSORBENT 15" X 20" L/F (10) GAUZE SPONGE 4" X 4" 16PLY (1) SAFETY IV INTROCAN 18 X 1Y. ST. LIF (1) NEEDLE HYPODERMIC 18G X 1Y:z (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) SKIN MARKER INK W/8 LABEL (2) TUBE SUCTION…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2431-2014·2014-09-10

    Customed Recalls Angiography Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,196 units of Angiography Packs across 21 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50" x 90" LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (2) CUP MEDICINE 2oz LIF (2) UTILITY BOWL 32oz LIF (1) EMESIS BASIN 101N 700cc (4) TOWEL CLAMP (3) TOWELS ABSORBENT 15" x 20" LIF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2328-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 552 units of EO sterilized surgical packs because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.

    Product
    LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2) LEGGINS WITH 7" CUFF (1) LAPAROSCOPY T SHEET SMS (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) *ROBIN REDRUBBER CATHETER 14FR LATEX (1) DRAPE LASER CAMERA W/EL LIF (1) PAD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2473-2014·2014-09-10

    Customed Recalls Orthopedic Surgical Packs Due to Potential Sterility Loss

    Customed, Inc. is recalling specific lots of Orthopedic Pack III surgical packs because packaging integrity may be compromised, risking patient injury from contamination or loss of sterility.

    Product
    ORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS REINFORCED (4) DRAPE UTILITY WffAPE (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) DRAPE TOP W/ADHESIVE 108" X 50" STD SMS (1) DRAPE ORTHOPEDIC SPLIT (1) U- DRAPE 60" X 70" WffAPE SPLIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2532-2014·2014-09-10

    Customed Recalls Cardiovascular Case Carts Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 48 units of Cirugia Cardiovascular Case Carts because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR .(INDUCCION) (1) CIRUGIA CARDIOVASCULAR (CIRUGIA ) (1) CIRUGIA CARDIOVASCULAR (PREP ENFERMERA CIRCULANTE) (1) CIRUGIA CARDIOVASCULAR (PERFUSION SUPPLIES) (1) CIRUGIA CARDIOVASCULAR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2449-2014·2014-09-10

    Customed Recalls Cervical Surgical Packs Due to Potential Packaging Integrity Issues

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

    Product
    CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60" X 77" DRAPE REINFORCED (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) SKIN MARKER W/RULER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2478-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 63 arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Arthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH (3) STRIPS TAPE 24" X 4" (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT Y4"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2480-2014·2014-09-10

    Customed Extremity Pack Recall Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Extremity Packs (code 900-2615) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC BANDAGE WITH VELCRO 4 X 5 (2) BLADE SURGICAL# 15 STAINLES STEEL (4) DRAPE UTILITY WITH TAPE (1) GOWN XL SMS IMPERVIOUS REINFORCED ( 1) GOWN SURG REINFORCED LARGE TOWEL & WRAP (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2428-2014·2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling General Packs containing surgical supplies because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER REINFORCED LIF ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (2) UTILITY BOWL 16 oz. LIF (1) GLASINE BAG PLAIN ( 1) SUTURE BAG FLORAL (4) DRAPE UTILITY WITH TAPE LIF ( 1) TABLE COVER…
    Category
    Medical Device
    Distribution
    Distributed nationwide