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.

25001–25025 of 32194

  • SevereFDA (Devices)·Z-2494-2014·2014-09-10

    Customed Recalls Liposuction Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Liposuction Packs (code 900-2681) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Liposuction Pack, code 900-2681, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE (1) TUBE SUCTION CONNECT (1) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 (1) RULER 6 CLEAR (12) TOWELS CLOTH HUCK (BLUE) (1 0) LAP SPONGE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2421-2014·2014-09-10

    Customed Recalls Universal Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Universal Packs containing surgical instruments and supplies because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 20G X 1 1!2 (2) GOWN X-LARGE SMS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2463-2014·2014-09-10

    Customed Recalls C-Birth Pack II Due to Potential Packaging Integrity Issues

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

    Product
    C - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF (4) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN XLGE SMS IMPERVIOUS REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BLANKET BABY 30" X 30" POLYABS IMPERVIOUS LIF (1) SYRINGE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2515-2014·2014-09-10

    Customed Recalls Hair Restoration Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Hair Restoration Packs (code 900-2966) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Hair Restoration Pack- , code 900-2966, contains: (1) MAYO STAND COVER 23X54 (2) TOWEL CLOTH HUCK BLUE (2) TABLE COVER BACK ZONE REINFORCED 44 X 90 (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (2) TOWEL ABSORBENT 15 X 20 (1) MINDE KNIFE 1.0MM, WIDE, 40 DEGREE ANGLE, 6.0MM IN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2507-2014·2014-09-10

    Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns

    Customed is recalling 402 units of Orthopedic Pack Basic (Code 900-2830) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53" X 77" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET SPLITW/ADHES…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2322-2014·2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,564 units of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    CESAREAN PACK - - (1) MAYO STAND COVER REINFORCED LIF (20) LAP SPONGES PRE-WASH XRD LIF (1) UMBILICAL CORD CLAMP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) BEANNIES BABY (1) POLISHER TIP CAUTERY LIF (1) LITE GLOVE L/F (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2365-2014·2014-09-10

    Customed Recalls PERl GYN PACK Surgical Kits Due to Packaging Integrity Concerns

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

    Product
    PERl GYN PACK (1) TABLE COVER 44" x 90" (2) LEGGINS W/7" CUFF 30" x 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (2) TOWELS ABSORBENT 15" X 20" (10) GAUZE SPONGE 4" X 4" 16PLY (2) DRESSING NON ADH TELFA 4" X 3" (1) ROBINSON RED CATHETER 14FR. (1) UNDERBUTTOCK DRAPE WITH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1581-2014·2014-09-10

    Apotex Recalls PAXIL Tablets Due to Chemical Contamination

    Apotex Inc. is recalling specific lots of PAXIL (Paroxetine HCL) 20 mg tablets because they were manufactured with active pharmaceutical ingredients contaminated with residual materials and solvents.

    Product
    PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3664-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2495-2014·2014-09-10

    Customed Recalls Breast Augmentation Packs Due to Packaging Integrity Concerns

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

    Product
    Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1577-2014·2014-09-10

    Apotex Recalls Paroxetine Hydrochloride Tablets Due to Chemical Contamination

    Apotex Inc. is recalling specific lots of Paroxetine Hydrochloride Controlled-Release Tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.

    Product
    PAROXETINE HYDROCHLORIDE — PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2489-2014·2014-09-10

    Customed Recalls Liposuction Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling specific lots of Liposuction Pack MRT due to potential packaging integrity issues that could compromise sterility.

    Product
    Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1) MAYO STAND COVER REINFORCED LIF (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF ( 1) PVP SCRUB SOLUTION 4oz BOTTLE (20) GAUZE SPONGES 4 X 4 (12) TOWEL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2475-2014·2014-09-10

    Customed Recalls Minor Surgical Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Minor Pack 900-2511 surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Minor Pack 900-2511, pack contains: (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII (10) GAUZE SPONGE 4" X 4" 16PLY XRD (5) LAP SPONGE PREWASH 18" X 18" XRD (1) DRAPE LAPAROTOMY W/POUCH 100" x 72" x 124" (4) DRAPE UTILITY WITH TAPE (2) DRAPE SHEET 41" X 69" MEDIUM ( 1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2311-2014·2014-09-10

    Customed Recalls Open Heart Surgical Trays Due to Packaging Integrity Concerns

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

    Product
    OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) TRAY PLATO LARGE (3) DRESSING NON ADH TELFA 8 X 3 (2) BAG GLASSINE PLAIN (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) NEEDLE HYPODERMIC 27G X 'h" (4)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2401-2014·2014-09-10

    Customed Recalls Dressing Change Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 2,950 units of Dressing Change packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ( I) DRESSING TEGADERM 3 Y2 X 4 Y2 ( I) MASK PROCEDURAL YELLOW 80MM HG L/F (4) GAUZE 4" X 4" 4PLY ( I) ALCOHOL PREP PAD MED ( I) CI-ILORASCRUB SWABSTICK 1.6 ( I) LABELCAUTION ( I) DRAPE NON…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2395-2014·2014-09-10

    Customed Recalls EO Sterilized ENT Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 39 lots of EO sterilized ENT surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED L/F (1) TUBE SUCTION CONNECT %" X 12' L/F (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2531-2014·2014-09-10

    Customed Recalls Open Heart Surgical Trays Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Open Heart Tray, Pack A (code 900-1196C) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1) CARDIOVASCU.LAR INCISE DRAPE L/Free (2) 3/4 ABS. REINFORCED SHEET (1) PLASTIC SHEET (5) DRAPE SHEET SMS (18) CLOTH HUCK TOWELS Blue (4) CLOTH HUCK TOWELS White (1 0) ABSORBENT TOWELS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2522-2014·2014-09-10

    Customed Recalls Face Lift Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Face Lift surgical packs (Code 900-3083) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE REINFORCED 50" X 90" LIF (I) DRAPE HEAD WITH TAPE 44" X 26" LIF (I) COVER MAYO STAND REINFORCED LIF (I) BAG SUTURE FLORAL LIF (3) GOWN STANDARD LARGE SMS VEL/NE LABEL SAMPLE (I)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2436-2014·2014-09-10

    Customed Recalls Femoral Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 432 units of Femoral Packs because compromised packaging may allow product contamination or loss of sterility.

    Product
    FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SHEET 42" X 57" SMS LIF (1) SAFETY IV INTROCAN 18 X 1X ST. LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF (2) VESSEL LOOP SURGICAL MAXI BLUE (1) SUTURE AID BOOT STD YELLOW ST. LIF (1) YANKAUER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2403-2014·2014-09-10

    Customed Recalls Retina Pack Surgical Kits Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 336 units of Retina Pack surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78" LIF (50) COTTON TIP APPLICATOR 6" WOOD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (2) MEDECINE CUP 2oz LIF (5) TOWELS ABSORBENT 15" X 20" LIF ( 1) UNIVERSAL EYE SHIELD (1) EYE DRAPE (1) BIPOLAR CABLE DISPOSABLE (…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2503-2014·2014-09-10

    Customed Recalls Minor Packs Due to Potential Packaging Integrity Compromise

    Customed, Inc. is recalling 200 units of EO sterilized minor packs because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" (16) GAUZE SPONGES 2" X 2" 8PLY (1) TRAY HALF SHALLOW (12) COTION TIP APPLICATOR 6" WOOD (2) GLOVE SKY NITRILE PF BLUE MED (18) GAUZE SPONGES 4" X 4" 12PLY (1) SMALL DRAPE W/ADH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2367-2014·2014-09-10

    Customed Recalls OB Packs Due to Potential Packaging Integrity Issues

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

    Product
    OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) DRAPE UNDERBUTIOCK W/ POUCH 44" X 35" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (2) PAD OBSTETRICAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2412-2014·2014-09-10

    Customed Recalls Ophthalmic Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,382 units of ophthalmic packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL ABSORBENT 15" x 20" UF (1) SYRINGE 3cc W/NEEDLE 21 G X 1 Y. UF (6) COTION TIP APPLICATOR 6" WOOD (1) TABLE COVER REINFORCED 50" X 90" UF (1) PAD EYE 2 1/8 X 2 5/8 (1) CYSTOTOMO…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2307-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 32 lots of Laparotomy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Customed Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent towel, scrub, stck sponges/ gauzes, table cover, drape sheet, suture bag, duraprep surgical solution, cloth huck towels, utility bowls, suction tube, scalpel, Mayo Tray, Mayo…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2432-2014·2014-09-10

    Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TABLE COVER BTC 77" X 11 0" HD FULL COVERAGE LIF (1) MAYO STAND COVER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2468-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

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

    Product
    LAPAROTOMY PACK 1 (2&3) CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHffAPE (1) SUTURE BAG FLORAL (1) DRAPE T LAPAROT 102" X 78" X 121" STD SMS (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO…
    Category
    Medical Device
    Distribution
    Distributed nationwide