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.

276–300 of 333

  • HighFDA (Devices)·Z-2308-2014·2014-09-10

    Customed Recalls Femoral Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 855 units of Customed Femoral Packs because packaging integrity may be compromised, potentially leading to loss of sterility or patient injury.

    Product
    Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze/sponges, table cover, absrobent towels, halsted Mosquito CVD, gown, bowls, wrapper, scalpel safety, Mosquito forcep, cloth huck, clamp towel,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2369-2014·2014-09-10

    Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 1,671 units of Laparoscopy Chole Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SURGICAL DURAPREP SOLUTION 26ml LIF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) DRAPE LASER CAMERA W/EL 6" X 96" (1) LAPAROSCOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2409-2014·2014-09-10

    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) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) COUNTER NEEDLE & BLADE 10C MAG/CL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2449-2014·2014-09-10

    Customed Recalls Cervical Surgical Packs Due to Potential Packaging Integrity Issues

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

    Product
    CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60" X 77" DRAPE REINFORCED (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) SKIN MARKER W/RULER (1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2417-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS ABSORBENT LIF (10) GAUZE SPONGES XRD 4" X 4" 12PLY (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WIT APE L/F EO sterilized surgical convenient packs packaged into polyester/polyethyle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2466-2014·2014-09-10

    Customed Recalls Laparoscopy ABO Packs Due to Packaging Integrity Concerns

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

    Product
    LAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15" X 20" (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITH TAPE (1) SUTURE BAG FLORAL (1) DRAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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
  • HighFDA (Devices)·Z-2393-2014·2014-09-10

    Customed Recalls Reyito Urology Packs Due to Potential Sterility Loss

    Customed, Inc. is recalling 2,900 units of Reyito Urology Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF ( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF ( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF ( I) BAG SUTURE (I) TABLE COVER ( I} TUBE SUCTION CONNECT. W' X 12' UF (10) GAUZE SPONGES 4" X 4"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2014·2014-09-10

    Customed Recalls Labor and Delivery Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 1,852 units of Labor & Delivery Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15" X 20" ( 1) FEEDING TUBE 8FR, 15" LONG ( 1) BEANNIES BABY ( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK ( 1) UMBILICAL CORD CLAMP ST. ( 1) RECEIVING BLANKET 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    BASIC PACK W/OUT GOWN- (1) TABLE COVER REINFORCED 50" X 90" UF (4) DRAPE UTILITY WITH TAPE UF (1) TOWEL ABSORBENT 15" x 20" L/F (1) SUTURE BAG FLORAL (1) DRAPE SHEET 42" X 57" SMS g~ SHEET o/. 57" X 63" REINFORCED SMS UF MAYO STAND COVER REINFORCED UF EO sterilized surg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2359-2014·2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,784 units of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) BABY BLANKET PRINTED (1) BOWL PLASTIC WITH LID 80oz. (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CORD UMBILICAL CLAMP (1) MUCUSTRAP 20cc, 10FR. (1) BOWL UTILITY 32oz (1) C-SECTION DR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2378-2014·2014-09-10

    Customed Recalls Laparoscopy OB GYN Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 345 units of Laparoscopy OB GYN Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T LAPAROSCOPY SMS LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DRAPE SHEET 41" X 58" SMS LIF (4) ABSORBENT TOWELS 15" x 20" LIF (1) PVP TRIPLE SWABSTICK IODOPHOR (1) DRAPE LASER CAMERA W/EL 6" X 96" (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2014·2014-09-10

    Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 2,192 units of Laparoscopy Chole Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF ( 1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) GOWN XL SMS IMPERVIOUS REINFORCED L/F (5) TOWELS ABSORBENT 15" X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2334-2014·2014-09-10

    Customed Recalls Laparoscopy Cholecystectomy Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 40 units of laparoscopy cholecystectomy surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP (1) BLADE SURGICAL #11 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) GOWN XLARGE SMS IMPERV. REINF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2014·2014-09-10

    Customed Recalls Obstetrical Surgical Packs Due to Potential Packaging Integrity Issues

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

    Product
    Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100 COTTON (3) TOWEL ABSORBENT 15 X 20 LIF (10) GAUZE SPONGE 4 X 4 16PLY XRD LIF (1) SYRINGE EAR/ULCER 2oz. LIF (1) DRAPE ABDOMINAL WITH TAPE 40X54 LIF (2) LEGGINS W/7'' CUFF 30X42 L/F (1) GOWN XL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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
  • HighFDA (Devices)·Z-2433-2014·2014-09-10

    Customed Recalls Open Heart Surgical Tray Packs Due to Packaging Integrity Concerns

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

    Product
    OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBENT 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80" (12) % SHEET 60" X 77" DRAPE REINFO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2014·2014-09-10

    Customed Liposuction Surgical Packs Recalled for Potential Sterility Loss

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

    Product
    Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) NEEDLE HYPODERMIC 25 X 1 LIF (1) BOWL UTILITY QUART 32oz LIF (1) COVER MAYO STAND REINFORCED L/F (20) GAUZE SPONGE 4" X 4" 16PLY LIF (1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2506-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 360 units of laparotomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROT 102" X 78" X 121" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN XL SMS IMPERVIOUS RE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2478-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 63 arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Arthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH (3) STRIPS TAPE 24" X 4" (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT Y4" X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2014·2014-09-10

    Customed Recalls Cystoscopy Packs Due to Potential Packaging Integrity Issues

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

    Product
    CYSTOSCOPY PACK Ill (1) (2) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W/7" CUFF 30" X 42" (1) DRAPE CYSTOSCOPY T 60" X 87" 35" SMS STD (1) GOWN SURG.REINFORCED XL EXTRA LONG LEVEL IV Product Usage: EO steri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2386-2014·2014-09-10

    Customed Recalls Premium Arthroscopy Packs Due to Packaging Integrity Concerns

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

    Product
    PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1) IMPERVIOUS STOCKINETTE (3) STRIPS TAPE 24" X 4" (1) DRAPE U WITH TAPE SPLIT (2) TOWELS ABSORBENT 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) GOW SURG. REINFORCED LARGE TOWEL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2497-2014·2014-09-10

    Customed Recalls Debridement Trays Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling specific lots of Debridement Trays (code 900-2702) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE SPONGES 4 X 4 12PL Y (1) SCISSORS IRIS STRAIGHT 4.5 W/PROTECTOR TIP (1) TOWEL 3 PLY POLY 13 X 18 (1) DRAPE 18 X 26 WHITE/WHITE POLYPROPYLENE (1) CHLORASCRUB SWABSTICK 1.6 ML (1) TRAY KUTIE
    Category
    Medical Device
    Distribution
    Distributed nationwide