The Recall Desk

Hazard

Loss Of Sterility recalls

333 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
333
Critical
26
Severe
45
Most recent
2026-08-12

Of the 333 loss of sterility recalls we have scored against our rubric, 26 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (14%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all loss of sterility recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

201–225 of 333

  • HighFDA (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
  • HighFDA (Devices)·Z-2385-2014·2014-09-10

    Customed Recalls Premium O.B. Packs Due to Packaging Integrity Concerns

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

    Product
    PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GAUZE SPONGES 4" X 4" 12PLY LIF (2) LEGGINS WITH 7" CUFF 30" x 42" LIF (2) PAD OBSTETRICAL X-LARGE ST. (2) SHEET DRAPE 42" X 55" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH LIF (1) DRAPE ABDOMINAL 40" X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2014·2014-09-10

    Customed Recalls Ortho Implant Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" (1) TUBE SUCTION CONNECT. }4" X 12' (1) DURAPREP SURGICAL SOLUTION 26ml (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2499-2014·2014-09-10

    Customed Recalls Knee Arthroscopy Packs Due to Packaging Integrity Concerns

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

    Product
    Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (10) GAUZE SPONGES 4 X 4 16PLY XRD (3) NEEDLE HYPODERM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2014·2014-09-10

    Customed Recalls Foley Catheter Kits Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 13 lots of Foley Catheter Kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PL Y POLY 17" X 18" (2) SWABSTICK DRY COTTON (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 81
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 polyester/polyeth
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 OBST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 (POST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2014·2014-09-10

    Customed Recalls Premium Urology Packs Due to Potential Sterility Loss

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

    Product
    PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT TOWELS UF (1) MAYO STAND COVER REINFORCED UF (1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF (1) GOWN SURG. REINFORCED LARGE T/WRAP (1) UTILITY BOWL 32 OZ. (1) TUBE SUCTION CONNEC. W' X 12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2014·2014-09-10

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

    Customed, Inc. is recalling 20 lots of EO sterilized surgical gown packs because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 REINFORCE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2380-2014·2014-09-10

    Customed Recalls OB Packs Due to Potential Packaging Integrity Compromise

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

    Product
    OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1) PLASTIC BOWL W/Lid 70 oz. (1) EAR/ULCER SYRINGE 2oz. L/Free (1) UMBILICAL CORD CLAMP (1) BABY BEANNIES (1) PVP SCRUB 8" STICK SPO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2014·2014-09-10

    Customed Recalls Laminectomy Packs Due to Potential Packaging Integrity Issues

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

    Product
    LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF ( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POLISHER LIF ( I) TUBE SUCTION CONNECT. W' X 12' LIF (6) DRAPE UTILITY W/TAPE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (2) UTILITY BOWL 16o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2014·2014-09-10

    Customed Recalls Pery Gyn Packs Due to Potential Packaging Integrity Issues

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

    Product
    PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (1) DRAPE UNDERBUTTOCK WITH POUCH (1) UTILITY BOWL 16oz. (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) ROBNEL CATHETER 18FR. (1) DRAPE SH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2348-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 3,066 units of EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRAPE SHEET 41 " X 58" SMS (1) BANDAGE GAUZE 4" STRETCH (1) NEEDLE HYPODERMIC 25G X 5/8" (1) STOCKINETTE 6" X 48" LIF (2) CLOTH HUCK T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 AB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 IMPER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2355-2014·2014-09-10

    Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,900 units of EO sterilized urology packs across 36 lots because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF (2) GOWN SURG. REINFORCED LARGE TOWEL & WRAP (1 0) GAUZE SPONGE 4" X 4" 12 PLY (1) URINARY DRAINAGE BAG 2000ML ANTI-REFLUX LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LITHO 110" X 63" SMS WITH LEGGINS (3) TOWELS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2014·2014-09-10

    Customed Recalls Universal Pack II Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    Universal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER REINFORCED (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTTOM ABSORBENT REINFORCED 71" X 62" STD SMS WITH TAPE (1) DRAPE TOP W/ADHESIVE 1 08" X 50" STD SMS (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 50" X 9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2443-2014·2014-09-10

    Customed Recalls Neuro Packs Due to Potential Packaging Integrity Compromise

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

    Product
    NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4" X 4" 1 6PLY XRD UF ( I ) CAUTERY POLISHER TIP LIF ( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE (8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,300 laparotomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 41 II X 58" SMS L/F ( 1) TABLE COVER 50" X 90" LIF ( 1) SOLUTION SURGICAL DURAPREP 26ML
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 EAR/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2014·2014-09-10

    Customed Recalls Colorectal Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 626 units of Laparoscopia Colorectal Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE UTILITY WITH TAPE (1) TOWELS ABSORBENT 15" X 20" (2) LEGGINS W/7" CUFF 30" X 42" (1) BLADE SURGICAL #15 STAINLESS STEEL (1) BLADE SURGICAL #11 STAINLESS STEEL (1) GOWN IMPER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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) M
    Category
    Medical Device
    Distribution
    Distributed nationwide