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
220
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 220 (66%) 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

  • SevereFDA (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
  • SevereFDA (Devices)·Z-2376-2014·2014-09-10

    Customed Recalls PHACO PACK Surgical Kits Due to Packaging Integrity Concerns

    Customed is recalling 1,775 units of PHACO PACK surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    PHACO PACK - (10) GAUZE SPONGE 4" X 4" 12PLY (2) SYRINGE 3cc W/NDL. 21G X 1 %" (2) MEDICINE CUP 2 oz. (1) OPHTHALMIC DRAPE W/POUCH (1) GOWN STANDARD LGE.SMS (1) GOWN NON REINF. Lge. T/Wrap SMS (1) EYE SHIELD UNIVERSAL (1) TABLE COVER 44" X 90" (1) MAYO STAND COVER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2455-2014·2014-09-10

    Customed Recalls Surgical Ear Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 27 units of surgical ear packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.

    Product
    EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) NEEDLE HYPODERMIC 1 80 X I Y, ( I) WASI-l BASIN ROUND 6QT (I) INSTRUMENT POUCH 7 X I I 2 COMPART (I) STRIP STER I CLOSURE W' X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2416-2014·2014-09-10

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

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

    Product
    PERl GYN PACK - (1) TOWEL NON ABS. W/TAPE L/Free (1) DRAPE UNDERBUTTOCK W/POUCH (2) TOWELS ABSORBENT L/Free (2) LEGGINGS W/7" CUFF (1) DRAPE TOP WI ADHESIVE (1) TABLE COVER REINF. L/Free (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) CATHETER 14FR ROBIN NELAT PVC (2) GOWN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2339-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Towels Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 26 lots of EO sterilized surgical towels because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.

    Product
    O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20" X 20 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2314-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 1,485 units of EO sterilized surgical packs across 22 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    0.B. PACK - HSCH- (1) PVP SCRUB 8" STICK SPONGES (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (1) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) BOWL PLASTIC WITH LID 80oz LIF (1) RECEIVING BLANKET 100% COTTON (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2398-2014·2014-09-10

    Customed Recalls EO Sterilized Cardiovascular Surgical Packs Due to Packaging Concerns

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

    Product
    CIRUGIA CARDIOVASCULAR - CASE CART - (1) CIRUGIA CARDIOVASCULAR (PREPARACION) (1) CIRUGIA CARDIOVASCULAR (ENFERMERA CIRCULANTE) (1) CIRUGIA CARDIOVASCULAR (INDUCCION) (1) OPEN HEART TRAY EO sterilized surgical convenient packs packaged into polyester/polyethylene breather…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2362-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 46 lots of EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    STRABISMUS & PLASTIC PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) GOWN STANDARD LARGE SMS (3) TOWELS ABSORBENT 15" X 20" UF (1) MAYO STAND COVER REINFORCED UF (1) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical convenient packs…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2354-2014·2014-09-10

    Customed Recalls Cesarean Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 968 units of EO sterilized cesarean surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CESAREAN PACK- (1) BEANNIES BABY LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (3) SHEET DRAPE 41 " X 58" SMS LIF (5) TOWEL ABSORBENT 15" X 20" LIF (15) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (2)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2313-2014·2014-09-10

    Customed Recalls Angiography Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 30 lots of angiography packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF (2) MEDICINE CUP 2oz. LIF (3) UTILITY BOWL 32oz UF (1) EMESIS BASIN 10 IN 700cc (4) TOWEL CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • SevereFDA (Devices)·Z-2514-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Drape Sheets Due to Packaging Integrity

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

    Product
    Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X 24 L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2426-2014·2014-09-10

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

    Customed, Inc. is recalling 327 units of EO sterilized surgical shoulder packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER REINFORCED L/F (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (1) SHEET DRAPE 70"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2361-2014·2014-09-10

    Customed Recalls Cataract Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2450-2014·2014-09-10

    Customed Recalls Liposuction Packs Due to Potential Packaging Integrity Issues

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

    Product
    LIPOSUCTION PACK AESTHETIC SURG.CENTER CONTENTS: (1) BLADE SURG. #11 CARBON STEEL (3) * GLOVE PERRY SURG. # 7LATEX (15) SPONGE LAP PREWASH 18" X 18" XRD L/F (4) * GLOVE PERRY SURG. # 7 LATEX (1) TABLE COVER REINF 50" X 90" LIF (2) GOWN SOFT SMS STD XL SET IN SLEEVE L/F (4)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2397-2014·2014-09-10

    Customed Recalls D & C Laparoscopy Packs Due to Packaging Integrity Concerns

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

    Product
    D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) TRAY MAYO SMALL LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SUTURE BAG FLORAL LIF (1) TUBE SUCTION CONNECT X" X 12' LIF (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2517-2014·2014-09-10

    Customed Recalls Chole Cystectomy All Endo System Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Chole Cystectomy All Endo System kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO STAND COVER REINFORCED UF (1) NEEDLE HYPODERMIC (6) ABSORBENT TOWEL 15 X 20 UF (1) NEEDLE HYPODERMIC 22G X 1Y. UF (4) UTILITY DRAPE WIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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