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.

126–150 of 333

  • SevereFDA (Devices)·Z-2353-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,300 laparotomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 41 II X 58" SMS L/F ( 1) TABLE COVER 50" X 90" LIF ( 1) SOLUTION SURGICAL DURAPREP 26ML…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2461-2014·2014-09-10

    Customed Recalls Basic Pack 1 Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILITY WffAPE (2) TOWELS ABSORBENT 15" X 20" (1) SUTURE BAG FLORAL (1) DRAPE SHEET 42" X 57" SMS (1) SHEET :X 57" X 63" REINFORCED SMS (1) MAYO STAND COVER REINFORCED Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2477-2014·2014-09-10

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

    Customed, Inc. is recalling 20 lots of EO sterilized surgical gown packs because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" LIF 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2470-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,233 units of EO sterilized surgical laparotomy packs because packaging integrity may be compromised, risking product contamination or loss of sterility.

    Product
    LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" (2) GOWN XLARGE SMS IMPERVIOUS REINFORCED (1) COVER MAYO STAND REINFORCED (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROTOMY 102" X 78" X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2380-2014·2014-09-10

    Customed Recalls OB Packs Due to Potential Packaging Integrity Compromise

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

    Product
    OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1) PLASTIC BOWL W/Lid 70 oz. (1) EAR/ULCER SYRINGE 2oz. L/Free (1) UMBILICAL CORD CLAMP (1) BABY BEANNIES (1) PVP SCRUB 8" STICK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2430-2014·2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 420 units of EO-sterilized Cesarean Packs because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.

    Product
    CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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 ~…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2377-2014·2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 21 lots of Laparoscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE BANDAGE%" X 3" ST. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (2) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE LASER CAMERA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2419-2014·2014-09-10

    Customed Recalls AV Fistula Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV (1) DRAPE SHEET 42" X 57" SMS (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) TUBE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2530-2014·2014-09-10

    Customed Recalls Breast Surgical Packs Due to Potential Sterility Loss

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

    Product
    Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSORBENT 15" X 20" LIF (1) PENCIL CAUTERY PUSH BOTTOM LIF (1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F (1) TUBE SUCTION CONNECT X" X 12' LIF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2349-2014·2014-09-10

    Customed Recalls Carpal Tunnel Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE HYPODERMIC 18G X 1 % LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BOWL UTILITY QUART 32oz. (2) SHEET DRAPE 41" X 58" SMS LIF (2) TOWELS ABSORBENT 15" X 20" LIF (1) BANDAGE GAUZE STRETCH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2472-2014·2014-09-10

    Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF (1) DRAPE % ECONOMY 53" X 77" LIF (4) DRAPE UTILITY WIT APE LIF (1) BAG SUTURE FLORAL LIF (1) SHEET…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2518-2014·2014-09-10

    Customed Recalls Tummy Tuck Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (2) TOWELS ABSORBENT 15 X 20 (1) PENCIL CAUTERY PUSH BOTTOM (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (2) SKIN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2519-2014·2014-09-10

    Customed Recalls Face Pack BOD Due to Potential Packaging Integrity Issues

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

    Product
    Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWELS ABSORBENT 15" X 20" (1 ) DRAPE INSTRUMENT MAGNETIC 10" X 16" (1 ) TRAY HALF DEEP (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1 ) SHEET ENT SPLIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2439-2014·2014-09-10

    Customed Recalls Shoulder Arthroscopy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 1,707 units of Shoulder Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2) DRAPE SHEET 70" X 100" (1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST. (1) STOCKINETTE 6 X 48" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2496-2014·2014-09-10

    Customed Recalls Tummy Tuck Packs Due to Potential Packaging Compromise

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

    Product
    Tummy Tuck Pack, code 900-2684, contains: (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 (6) TOWEL CLOTH HUCK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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)…
    Category
    Medical Device
    Distribution
    Distributed nationwide