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.

226–250 of 333

  • HighFDA (Devices)·Z-2452-2014·2014-09-10

    Customed Recalls Ortho Pack Extremity Surgical Packs Due to Packaging Integrity

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

    Product
    ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) U-DRAPE 60" X 70" WfTAPE SPLIT (1) SHEET EXTREMITY ABS. 125" X 85" (1) GOWN SOFT SMS STD. XL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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
  • HighFDA (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 17
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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) PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2408-2014·2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 23 lots of EO-sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CESAREAN PACK - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F (3) DRAPE SHEET 41" X 58" SMS LIF (1) BABY BLANKET PRINTED LIF (1) BOWL PLASTIC 80oz WITH LID (1) TUBE SUCTION CONNECT.%" X 12' LIF (15) LAP SPONGE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2430-2014·2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 420 units of EO-sterilized Cesarean Packs because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.

    Product
    CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP SPONG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2333-2014·2014-09-10

    Customed Recalls Laparoscopy Cholecystectomy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 26 lots of Laparoscopy Cholecystectomy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO STAND COVER REINFORCED UF (1) BLADE SURGICAL #11 STAINLESS STEEL (1) DRAPE SHEET 41 " X 58" SMS UF (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) TUBE SUCTION CONNEC. 3/16" x 12' UF (3) TOWEL ABSO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2014·2014-09-10

    Customed Recalls Face Pack BOD Due to Potential Packaging Integrity Issues

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

    Product
    Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWELS ABSORBENT 15" X 20" (1 ) DRAPE INSTRUMENT MAGNETIC 10" X 16" (1 ) TRAY HALF DEEP (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1 ) SHEET ENT SPLIT 11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2438-2014·2014-09-10

    Customed Recalls HIP PACK Surgical Kits Due to Packaging Integrity Concerns

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

    Product
    HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG (1) DRAPE UTILITY WITH TAPE (1) STOCKINETTE IMPERV. 14" X 48" (1) U-DRAPE 54 X 72 WITH TAPE SPLIT HIP DRAPE 89" X 128" WITH POU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2368-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 432 units of Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE (1 ) ELASTIC BANDAGE 6" X 5yds LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG (1) TUBE SUCTION CONNECTING W X 12' LIF (1) SHEET EXTREMITY ABS. 125" X 85" SMS (1) DRAPE LASER CAMERA W/EL (3) TOWELS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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" L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2394-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 399 units of EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF ( I) TUBE SUCTION CONNECT \14'' X 12' LIF ( I) BAG GLASSINE LIF (2) LITE GLOVE LIF (2) TABLE COVER 50" X 90" REINFORCED LIF ( I) MAYO STAND COVER REINFORCED LIF (5) TOWEL ABSORBENT 15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2458-2014·2014-09-10

    Customed Recalls Knee Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Knee Arthroscopy Pack 4 units because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    KNEE ARTHROSCOPY PACK 4 CUSTOMED CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN SURG REINFORCED LARGE TOWEL WRAP AAMI LEVEL Ill (1) PRE PAD CUFF (1) COVER MAYO STAND REINFORCED (1) BAG SUTURE FLORAL (1) SHEET SPLIT WITH/ADHESIVE 108" X 77" STD SMS (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2014·2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed is recalling 1,095 units of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.

    Product
    CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND 4" x 10" (1) CESAREAN DRAPE 71" x 125" LIF (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP (10) LAP SPONGES PREWASH XRD LIF (1) BABY BEANNIES (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2406-2014·2014-09-10

    Customed Recalls PERY GYN PACK Surgical Drapes Due to Packaging Integrity Concerns

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

    Product
    PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWELS ABSORBENT 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1 ) TABLE COVER REINFORCED 50" X 90" UF (1) DRAPE ABDOMINAL WITH TAPE UF EO sterilized surgical convenient packs packaged int
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 X-LARGE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 COVER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2492-2014·2014-09-10

    Customed Recalls Breast Implant Packs Due to Potential Packaging Compromise

    Customed, Inc. is recalling 54 units of Breast Implant Packs (Code 900-2660) because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.

    Product
    Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (2) TABLE COVER REINFORCED 50 X 90 (1) SUTURE BAG FLORAL (1) TUBE SUCTION CONNECT Y (6) TOWE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2523-2014·2014-09-10

    Customed Recalls General Cosmetic Pack Due to Packaging Integrity Concerns

    Customed, Inc. is recalling General Cosmetic Pack FCSC (Code 900-3113) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    General Cosmetic Pack FCSC, Code 900-3113, contains: (1) COVER MAYO STAND REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (2) GOWN LARGE STANDARD SMS AAMIIII (1) TABLE COVER REINFORCED 50" X 90" LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2482-2014·2014-09-10

    Customed Recalls Open Heart Packs Due to Potential Sterility Loss

    Customed, Inc. is recalling Open Heart Packs (code 900-2618) because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.

    Product
    Open Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (6) TOWELS ABSORBENT 15" X 20" L/F ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF ( 1) MAYO TRAY LARGE (8) DRAPE UTILITY WfTAPE LIF (1 ) TABLE COVER REIN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 COV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2377-2014·2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

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

    Product
    LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE BANDAGE%" X 3" ST. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (2) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE LASER CAMERA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2413-2014·2014-09-10

    Customed Recalls Laparoscopy Premium Packs Due to Packaging Integrity Concerns

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

    Product
    LAPAROSCOPY PREMIUM PACK - (1) TABLE COVER REINFORCED 50" x 90" UF (4) TOWEL ABSORBENT 15" x 20" UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) DRAPE LASER CAMERA W/EL UF (1) TROCAR ENDO.XCEL DILATING TIP (KSLT) (1) APPLIER CLIP 5MM (3) GOWN XLGE SMS IMPERV. REINFORCED (1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2351-2014·2014-09-10

    Customed Recalls General Minor Packs Due to Potential Sterility Loss

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

    Product
    GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16oz LIF (1) TIP CAUTERY POLISHER LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL UTILITY 32oz (1) BAG SUTURE FLORAL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2419-2014·2014-09-10

    Customed Recalls AV Fistula Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV (1) DRAPE SHEET 42" X 57" SMS (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) TUBE SUCT
    Category
    Medical Device
    Distribution
    Distributed nationwide