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.

25076–25100 of 32194

  • SevereFDA (Devices)·Z-2501-2014·2014-09-10

    Customed Recalls Surgical Gown Packs Due to Packaging Integrity Concerns

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

    Product
    Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains: (1) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE (1) TOWEL ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2364-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 3,603 units of EO sterilized laparotomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD LIF (1) LITE GLOVE LIF (1) BAG SUTURE FLORAL (1) BLADE SURGICAL #1 0 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) YANKAUER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2521-2014·2014-09-10

    Customed Recalls Breast Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT%" X 12' (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2462-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Arthroscopy Pack I units because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (1) U - DRAPE 60" X 70" WITAPE SPLIT 6 X 21 (1) SHEET SPLIT W/ADHESIVE 108" X 77" STD SMS (1) STOCKINETTE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2479-2014·2014-09-10

    Customed Recalls Hip and Knee Replacement Packs Due to Sterility Concerns

    Customed, Inc. is recalling Hip & Knee replacement packs (900-2614) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) MAYO STAND COVER REINFORCED UF (5) TOWELS ABSORBENT 15" X 20" UF (2) DRAPE SHEET 70" X 100"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2329-2014·2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

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

    Product
    LAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY 53" X 77" LIF (1) TUBE SUCTION CONNECT. v.i" X 12' LIF (1) SCALPEL WITH HANDLE #11 (1) DRAPE LAP ABDOMINAL WITH POUCH 1 02" X 122" X 78" LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (8) TOWEL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2490-2014·2014-09-10

    Customed Recalls Tummy Pack MRT Surgical Kits Due to Packaging Integrity Concerns

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

    Product
    Tummy Pack MRT, code 900-2657, contains: (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) NEEDLE ULTRACLEAN 1" (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG ( 1) BOWL UTILITY QUART 32oz (1 ) MAYO STAND…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2315-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 3,576 units of EO sterilized laparotomy packs because packaging integrity may be compromised, risking loss of sterility and patient injury.

    Product
    LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER IOC MAG/CLEAR ( I) DRAPE T LAPAROTOMY STD SMS (2) TOWELS ABSORBENT 15" x 20" (2) GOWN IMP. REINFORCED LARGE SMS (4) DRAPE UTILITY WITH TAPE ( I)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2505-2014·2014-09-10

    Customed Recalls Shoulder Packs Due to Potential Packaging Integrity Issues

    Customed is recalling 171 units of Shoulder Pack Code 900-2766 because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4" X 5YD WRAP TAN LATEX (2) U-DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TABLE COVER 44" X 90" (4) TOWELS ABSORBENT 15" X 20" LIF (2) TUBE SUCTION CONNECT" X 12' LIF (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2370-2014·2014-09-10

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

    Customed, Inc. is recalling 43 lots of PERl GYN PACK surgical kits because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (2) TOWELS ABSORBENT 15" X 20" UF (1) TOP DRAPE WITH ADHESIVE STD SMS (1) CATHETER NELATON ROB. 14FR. (2) GOWN IMPERVIOUS EXTRA REINFORCED XL (1) UNDERBUITOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) TABLE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2459-2014·2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

    Customed is recalling 567 units of 08 PAD PACK II surgical packs because packaging integrity may be compromised, risking product contamination or loss of sterility.

    Product
    08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE UNDERBUTTOCK W/POUCH (1) UMBILICAL CORD CLAMP (1) BABY BLANKET 30" X 30" POLY ABSOR.IMP. (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2491-2014·2014-09-10

    Customed Recalls Breast Pack MRT Surgical Kits Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 306 units of Breast Pack MRT surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK ( 1) NEEDLE and BLADE COUNTER 20c FOAM/MAG ( 1) UTILITY BOWL QUART 32oz ( 1) MAYO STAND COVER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2574-2014·2014-09-10

    Elekta FOCAL Sim Workstation Software Recall for Plan Mismatch

    Elekta is recalling FOCAL Sim Workstation software versions 4.70.00 and 4.80.00 because exported arc plans may not match approved treatment plans.

    Product
    FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2402-2014·2014-09-10

    Customed Recalls Universal Surgical Packs Due to Potential Sterility Loss

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

    Product
    UNIVERSAL PACK - (1) TRAY ORGANIZER FULL DEEP (1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE HYPODERMIC 20G X 1 ~ UF (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI Ill (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1987-2014·2014-09-10

    River Canyon Retreat Recalls Organic Carob Powder Due to Salmonella

    River Canyon Retreat is recalling Organic Carob Powder due to Salmonella contamination. The product was distributed in the US and Canada.

    Product
    Organic Carob Powder; Certified Organic, Product of Italy. Store in Cool, Dark place. Packaged in 16 oz., 5 lb., 20 lb and 55 lb. containers. 16 oz.. - 6 per case; 5 lb. - 6 per case; 20 lb. - 2 per case; 55 lb. - 1 per case. Earth Circle Organics; Grass Valley…
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-2418-2014·2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 882 units of laparoscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DRAPE ENDOSCOPY 1 00" X 123W' X 77" WITH TROUGHS (1) MAYO STAND COVER REINFORCED LIF (4) TOWEL ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (5) GAUZE SPONGE 2" X 2" 4PL Y (1) CORD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2474-2014·2014-09-10

    Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 612 units of Urology Pack 900-2510 because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF (10)GAUZE SPONGE 4" X 4" 12PL Y (1) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) TUR Y SET 81 " 2.1M REGULAR CLAM (1) GOWN SURG REINFORCED LGE TOWEL &…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1579-2014·2014-09-10

    Apotex Recalls PAXIL Tablets Due to Chemical Contamination

    Apotex Inc. is recalling PAXIL CR tablets because they were manufactured with active pharmaceutical ingredients contaminated with residual materials and solvents.

    Product
    PAXIL — PAXIL (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2512-2014·2014-09-10

    Customed Recalls TLIF Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP 26ML UF (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF (4) GOWN SOFT SMS STD XL SET IN SLEEVE UF (4) TOWELS ABSORBEN 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2445-2014·2014-09-10

    Customed Recalls Laparoscopic Colorectal Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2330-2014·2014-09-10

    Customed Recalls EO Sterilized Laparotomy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 550 units of EO sterilized laparotomy basic packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.

    Product
    LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO STAND REINFORCED UF (2) TOWEL ABSORBENT 15" X 20" UF (1 0) GAUZE SPONGES XRD 4" X 4"-12PL Y (2) DRAPE SHEET 41 " X 58" SMS UF (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2343-2014·2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 47 lots of EO-sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41" x 58" SMS LIF (2) TUBE SUCTION CONNECT. Y.." X 12' LIF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2434-2014·2014-09-10

    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 CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77" x 110" HD FULL COVERAGE LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SHEET 'I" 60" X 77" DRAPE REINF. LIF (2) SPECIMEN CONTAINER 4oz W/LID…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2454-2014·2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling specific lots of Total Hysterectomy surgical packs because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.

    Product
    TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF ( I) TUBING INSUFFLAT SET W/0 R ING ADAPTOR LIF (I) DRAPE VIDEO CAMERA 13cm X 244 em LIF ( I )…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2424-2014·2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 19 lots of EO-sterilized laparoscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES 120MM LIF ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III (1) MAYO STAND COVER…
    Category
    Medical Device
    Distribution
    Distributed nationwide