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.

176–200 of 333

  • HighFDA (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 REI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2420-2014·2014-09-10

    Customed Recalls Ophthalmic Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 1,812 units of ophthalmic surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0 NDL LILOCK UF (1) MAYO STAND COVER REINF. LIF (1) NEEDLE HYPODERMIC 18G X 1% ST. UF (10) EYE MICRO SPONGE UF (2) LABEL CONTRAST BLUE (1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2014·2014-09-10

    Customed Cysto Tur Pack Recalled for Potential Packaging Integrity Issues

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

    Product
    Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2014·2014-09-10

    Customed Recalls Minor Extremity Packs Due to Potential Sterility Loss

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

    Product
    MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE% ECONOMY 53" X 77" (1) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET EXTREM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 LI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2014·2014-09-10

    Customed Recalls Open Heart Surgical Trays Due to Packaging Integrity Concerns

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

    Product
    OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND COVER REINFORCED LIF (7) DRAPE UTILITY WITH TAPE L/F (8) HUCK CLOTH TOWELS WHITE L/F (20) HUCK CLOTH TOWELS BLUE LIF (1) MAYO TRAY LARGE LI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2425-2014·2014-09-10

    Customed Recalls Neuro Packs Due to Potential Packaging Integrity Issues

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

    Product
    TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( 1) BULB SYRINGE 60cc LIF ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE (2) LITE GLOVE ( 1) TUBE SUCTION CONNECT. Y.."
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2384-2014·2014-09-10

    Customed Recalls Premium Laparotomy Packs Due to Packaging Integrity Concerns

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

    Product
    PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) SPONGE LAP PR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2366-2014·2014-09-10

    Customed Recalls C-Section Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 30 lots of C-Section Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSORBENT 15" X 20" L/F (1) BABY BLANKET (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV (2) PAD OBSTETRICAL XL LIF (1) LITE GLOVE LIF (1) DR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2326-2014·2014-09-10

    Customed Recalls Minor Laparotomy Packs Due to Packaging Integrity Concerns

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

    Product
    MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) TOWELS ABSORBENT 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE (1) DRAPE%
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,620 units 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 (1 0) GAUZE SPONGES 4" X 4" 16PL Y (1) TUBE SUCTION CONNECTING X" X 12' LIF (1) IMP. STOCKINETTE (1) SURGICAL BLADE #11 STAINLESS STEEL (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~ (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~ LUE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2357-2014·2014-09-10

    Customed Recalls Curation Kits Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 16 lots of Curation Kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP APPLICATOR (4) PVP PREP SOLUTION 1 oz (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) EXAM GLOVES MEDIUM (1) WRAPPER 24" X 24" UF (1) PACKING TRAY EO sterilized surgical convenient packs packag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2014·2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

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

    Product
    LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF (2) LEGGINGS W/7'' CUFF 30" X 42" LIF (1) DRAPE UTILITY WITAPE L/F (1) SUTURE BAG FLORAL LIF (1) SHEET T LAPAROSCOPY SOFT 97" X 96" X 36 LIF" (1) TABLE COVER REINFORCED 44" X 78" L/F Produc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 540 units of Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARHTROSCOPY PACK- (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE (1) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (1) BAG SUTURE FLORAL (1) STOCKINETTE IMPERVIOUS 14" X 48" (4) STRIPS T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 st
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2375-2014·2014-09-10

    Customed Recalls Neuro Pack Surgical Kits Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 936 units of NEURO PACK surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF (1) INSTRUMENT POUCH (10) LAP SPONGE PRE-WASH XRD (1) Pk. SURGICAL STRIP W' X 6" (2) UTILITY BOWL 32oz (1) MAYO TRAY LARGE (9) SHEET DRAPE 41 " X 69" MEDIUM LIF (1) NEEDLE HYPODERMIC 18G X 1 LIF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2502-2014·2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 208 units of surgical packs for knee and hip replacements because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0 (I) STOCKrNETTE IMPE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2510-2014·2014-09-10

    Customed Recalls Basic Cosmetic Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 168 units of Basic Cosmetic Surgical Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE BREAST/CHEST SMS L/F (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) TUBE SUCTION CONNECT Yt" X 12' LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (1) STERI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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) SHEE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2332-2014·2014-09-10

    Customed Recalls Pery Gyn Pack Surgical Kits Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Pery Gyn Pack surgical kits 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" (1) DRAPE UTILITY (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERV. REINF. AAMI LEVEL Ill (1) DRAPE UNDERBUTIOCK W/POUCH 44" X 35" (1) TIME OUT BEACON NON WOVEN (1) BOWL UTILITY BLUE 16oz (1) BAG SUTURE FLORA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 SMS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2014·2014-09-10

    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) DRAPE UTILITY WITH TAPE UF (1) UNDERBUTTOCK DRAPE WITH POUCH (2) ABSORBENT TOWELS 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1) TABLE COVER REINFORCED 50" X 90" UF (1) ABDOMINAL DRAPE WITH TAPE UF (1) UTILITY BOWL 16oz. (1 0) GAUZE SPONGE 4" X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 (1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2411-2014·2014-09-10

    Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 14 lots of Urology Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    UROLOGY PACK - (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND 6QT. (1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN (1) BAG URINARY DRAINGAGE 2000ml ANTI-REFLUX (1) BAG SUTURE FLORAL (1) GOWN SURG. REINFORCED X-LARGE T/VIJRAP (1) TABLE COVER 44" X 90" UF (2) DRAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2014·2014-09-10

    Customed Recalls Universal Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Universal Packs containing surgical items due to potential packaging integrity issues that could compromise sterility.

    Product
    Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) BAG SUTURE FLORAL (1) DRAPE TOP WITH ADHESIVE 100" X 53"
    Category
    Medical Device
    Distribution
    Distributed nationwide