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.

201–225 of 333

  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2327-2014·2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,168 units of laparoscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE (3) DRAPE SHEET 41" X 58" SMS (1) TUBING INSUFFLAT SET…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2400-2014·2014-09-10

    Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,700 urology packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12' (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RING (1) TUR Y SET, 2 LEAD, ST. (1) BAG SUTURE FLORAL (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV (2) TOWEL CLAMP (1) DRAPE LITHOTOMY…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2451-2014·2014-09-10

    Customed Recalls Face Pack Aesthetic Surgery Kits Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 96 units of Face Pack Aesthetic Surgery kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR COTION 6" WOOD (60) GAUZE SPONGE 4" X 4" 16 PLY SOFT LIF (2) NEEDLE SPINAL ANEST 22G X 3 Y2 LIF (8) TOWELS CLOTH HUCK BLUE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (6) BLADE #15…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2337-2014·2014-09-10

    Customed Recalls Laparoscopy Gyn Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 648 units of Laparoscopy Gyn Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) LAPAROSCOPY SHEET "T" SMS (3) TOWELS ABSORBENT 15" X 20" (1) SURGICAL BLADE#11 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) LEGGINS WITH 7" CUFF 30" x 42"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2442-2014·2014-09-10

    Customed Recalls Surgical Ear Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 123 units of surgical ear packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc ( I ) GOWN XL SMS IM P. REINFORCED ( I ) NEEDLE HYPODERM IC 1 8G X I 'h ( I ) WASH BASIN ROUND 6QT ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT (I) STERI STR I P…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2318-2014·2014-09-10

    Customed Recalls Ophthalmic Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2325-2014·2014-09-10

    Customed Recalls Cysto TUR Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 29 lots of Cysto TUR Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2488-2014·2014-09-10

    Customed Recalls Face Pack MRT Due to Potential Packaging Integrity Issues

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

    Product
    Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) DRAPE INST. MAGNETIC 10 X 16 LIF (1) TRAY HALF DEEP (1) COVER MAYO STAND REINFORCED LIF (1) SHEET ENT SPLIT 110 X 77 SMS LIF (1) COVER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • SevereFDA (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)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2410-2014·2014-09-10

    Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 440 units of Urology Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    UROLOGY PACK - (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREATHABLE XL LEVEL IV (1) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (1) TUR Y SET, 81 "2 .1M REGULAR CLAM (1) TABLE COVER 44" x 90" (1) DRAPE LITHO 11 0" X 63" WITH POUCH /LEGGING FEN (1) TUBE SUCTION…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2319-2014·2014-09-10

    Customed Recalls Angiodrape Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 180 units of Angiodrape Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STANDARD LARGE SMS VELCRO NECK (2) NEEDLE HYPODERMIC 21G X 1 W' UF (1) TABLE COVER 44" X 90" (3) CLOTH HUCK TOWELS BLUE (2) UTILITY BOWL 16oz…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2526-2014·2014-09-10

    Customed Recalls Face Pack FJG Due to Potential Packaging Integrity Issues

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

    Product
    Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1) SHEET ENT SPLIT 11 0" X 77" SMS (1) COVER TABLE REINFORCED 44" X 78" (20) GAUZE SPONGE 4"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • SevereFDA (Devices)·Z-2534-2014·2014-09-10

    Customed Recalls Lithotomy Pack III Due to Potential Packaging Integrity Issues

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

    Product
    Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN LARGE STANDARD SMS VELCRO NECK (2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1) DRAPE UTILITY WITH TAPE (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2342-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 5,574 units of EO sterilized surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (3) TOWELS ABSORBENT 15" x 20" (1) PAD OBSTETRICAL X-LARGE (1) VAGINAL SPONGE XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide