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.

151–175 of 333

  • SevereFDA (Devices)·Z-2382-2014·2014-09-10

    Customed Recalls Premium Cesarean Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 730 units of Premium Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL PLASTIC 80oz WITH LID (10) LAP SPONGE PREWASH XRD LIF (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41 " X 58"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2311-2014·2014-09-10

    Customed Recalls Open Heart Surgical Trays Due to Packaging Integrity Concerns

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

    Product
    OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) TRAY PLATO LARGE (3) DRESSING NON ADH TELFA 8 X 3 (2) BAG GLASSINE PLAIN (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) NEEDLE HYPODERMIC 27G X 'h" (4) CO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2524-2014·2014-09-10

    Customed Recalls Tummy Tuck Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER (1) NEEDLE HYPODERMIC 22G X 1 Y2 (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) COUNTER NEEDLE & BLADE 20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2507-2014·2014-09-10

    Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns

    Customed is recalling 402 units of Orthopedic Pack Basic (Code 900-2830) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53" X 77" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET SPLITW/ADHES 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2476-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 93 units of Laparotomy Packs (900-2516) because packaging integrity may be compromised, risking product contamination or loss of sterility.

    Product
    Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I) BULB SYRINGE 60cc LIF (4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER ( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION TU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2387-2014·2014-09-10

    Customed Recalls Neuro Spine Packs Due to Potential Packaging Integrity Issues

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

    Product
    NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) ABSORBENT TOWELS 15" X 20" UF (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP (1) DURAPREP SURGICAL SOLUTION 26mL UF (1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2014·2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 19 lots of EO-sterilized laparoscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES 120MM LIF ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III (1) MAYO STAND COVER REINFORC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2487-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    Plastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF LGE TMJRAP LIF (1) MAYO STAND COVER REINF LIF (1) TABLE COVER REINF 50" X 90" LIF (4) (1) PVP PAINT 8" STICK SPONGE (2) DRAPESHEET 41X A¿MED LIF (3) TOWELS ABSORBENT 15 X 20 LIF (2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2460-2014·2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

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

    Product
    BASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY 53" X 77" (1) DRAPE SHEET 41" X 58" SMS (4) UTILITY DRAPE W/TAPE (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 44" X 78" (2) GOWN SOFT SMS S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2322-2014·2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,564 units of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    CESAREAN PACK - - (1) MAYO STAND COVER REINFORCED LIF (20) LAP SPONGES PRE-WASH XRD LIF (1) UMBILICAL CORD CLAMP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) BEANNIES BABY (1) POLISHER TIP CAUTERY LIF (1) LITE GLOVE L/F (1) C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2014·2014-09-10

    Customed Recalls Ophthalmic Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,382 units of ophthalmic packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL ABSORBENT 15" x 20" UF (1) SYRINGE 3cc W/NEEDLE 21 G X 1 Y. UF (6) COTION TIP APPLICATOR 6" WOOD (1) TABLE COVER REINFORCED 50" X 90" UF (1) PAD EYE 2 1/8 X 2 5/8 (1) CYSTOTOMO I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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) COU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2404-2014·2014-09-10

    Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 843 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) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET DRAPE 42" X 57" SMS (1) TUBE SUCTION CONNECT. %" X12' LIF (1) SURGICAL BLADE #10 STAINLESS STEEL (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LAPAROSC. ABD 102" X 122" X 78" WITH POUC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2014·2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 154 units of Laparoscopy packs (Code 900-3178) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV (4) TOWEL ABSORBENT 15" X 20" LIF (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2447-2014·2014-09-10

    Customed Recalls Laparoscopy Chole System Packs Due to Packaging Integrity Concerns

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

    Product
    LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2508-2014·2014-09-10

    Customed Recalls Cysto TUR Packs Due to Potential Sterility Loss

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

    Product
    CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1) COVER TABLE REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill (1) TUR CYSTO IRRIGATION SET 79" SINGLE (1) TIME OUT BEACON NON WOVEN ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2014·2014-09-10

    Customed Major Laparotomy Pack Recalled for Potential Sterility Loss

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

    Product
    Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, gauze/sponges, drape, surgical blades, utility bowls, towels, tube suction, cautery tip, gown, and labels. EO steriliz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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
  • HighFDA (Devices)·Z-2505-2014·2014-09-10

    Customed Recalls Shoulder Packs Due to Potential Packaging Integrity Issues

    Customed is recalling 171 units of Shoulder Pack Code 900-2766 because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4" X 5YD WRAP TAN LATEX (2) U-DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TABLE COVER 44" X 90" (4) TOWELS ABSORBENT 15" X 20" LIF (2) TUBE SUCTION CONNECT" X 12' LIF (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2432-2014·2014-09-10

    Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TABLE COVER BTC 77" X 11 0" HD FULL COVERAGE LIF (1) MAYO STAND COVER R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2014·2014-09-10

    Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 681 units of Laparoscopy Chole Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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) SYRINGE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2495-2014·2014-09-10

    Customed Recalls Breast Augmentation Packs Due to Packaging Integrity Concerns

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

    Product
    Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 CLE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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