The Recall Desk

Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,235
Critical
4
Severe
260
Most recent
2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) 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 sterility compromise 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.

1826–1850 of 2235

  • HighFDA (Devices)·Z-1273-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling 16,410 units of BD PosiFlush Saline Flush Syringes included in various device kits because open seals may impact product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain catheter kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in various catheter kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1275-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Flush Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain device kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2015·2015-03-18

    Medela Recalls Sterile Enteral Feeding Syringes Due to Packaging Breach

    Medela Inc. is recalling sterile enteral feeding syringes because a potential packaging breach may have compromised their sterility.

    Product
    - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2015·2015-03-11

    Zipline Medical Recalls Zip 16 Surgical Skin Closure Devices

    Zipline Medical is recalling Zip 16 Surgical Skin Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2015·2015-03-11

    Zipline Medical Recalls Zip 8M Wound Closure Devices Due to Sterility Concerns

    Zipline Medical is recalling Zip 8M Wound Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1226-2015·2015-03-11

    Intuitive Surgical Recalls Vacuum Source Tubing Sets for Sterility Concerns

    Intuitive Surgical is recalling 706 Vacuum Source Tubing Sets for the EndoWrist Stabilizer because shipping damage may have compromised the sterile packaging.

    Product
    Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1135-2105·2015-03-04

    Zimmer CoCr Femoral Heads Recalled for Potential Sterile Tray Compromise

    Zimmer GmbH is recalling 6,109 CoCr femoral heads due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.

    Product
    CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1133-2015·2015-03-04

    Zimmer Metasul Femoral Head Recalled for Potential Sterile Tray Compromise

    Zimmer GmbH is recalling 30 Metasul Femoral Head units due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.

    Product
    Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1136-2015·2015-03-04

    Zimmer Metasul Femoral Head Recalled for Potential Sterile Tray Compromise

    Zimmer GmbH is recalling 16 Metasul Femoral Heads due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.

    Product
    Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Drugs)·D-0380-2015·2015-02-04

    Baxter Recalls Fluconazole Injection Bags Due to Seal Defects

    Baxter Healthcare is recalling 31,130 bags of Fluconazole Injection due to potential leaks from incomplete seals, which may compromise sterility.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0334-2015·2015-01-14

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Hospira Inc. is recalling 30,840 bags of 0.9% Sodium Chloride Injection, USP, 100mL, due to a potential leak at the administrative port that compromises sterility.

    Product
    0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2015·2015-01-07

    Atricure CryoICE Cryogenic Probe Recalled for Potential Sterility Compromise

    Atricure Inc is recalling 19,190 CryoICE cryogenic probes due to packaging defects that may have compromised sterility.

    Product
    Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0861-2015·2014-12-31

    US Endoscopy Recalls UroSeal Valves Due to Sterile Seal Integrity Issues

    US Endoscopy Group Inc is recalling 100 units of UroSeal Adjustable Endoscopic Valves because the sterile pouch seals may not be intact.

    Product
    UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0805-2015·2014-12-24

    AMS Monarc Subfascial Hammock Kits Recalled for Packaging Integrity Concerns

    American Medical Systems is recalling Monarc + and Monarc C Subfascial Hammock kits because routine testing showed the sterile packaging might fail during extreme shipping.

    Product
    AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0297-2015·2014-12-17

    Fresenius Kabi Recalls Cyanocobalamin Vials Due to Sterility Concerns

    Fresenius Kabi USA is recalling 240,550 vials of Cyanocobalamin Injection due to potential glass fractures and particles that compromise sterility.

    Product
    CYANOCOBALAMIN — CYANOCOBALAMIN (CYANOCOBALAMIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0383-2015·2014-12-10

    Customed Minor Laparotomy Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 250 Minor Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0358-2015·2014-12-10

    Customed Tummy Tuck and Liposuction Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling six Tummy Tuck & Liposuction Packs due to compromised sterility and manufacturing deficiencies that pose a risk of patient infection.

    Product
    Tummy Tuck & Liposuction Pack, catalog #900-2661 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0408-2015·2014-12-10

    Customed Plastic Surgery Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 105 Plastic Surgery Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Plastic Surgery Pack, Catalog # 900-920 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0382-2015·2014-12-10

    Customed Cysto Tur Pack Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 75 units of Cysto Tur Pack (Catalog 900-430) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0372-2015·2014-12-10

    Customed Face Lift Recall Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 20 units of Face Lift products (Catalog 900-3083) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Face Lift, Catalog number 900-3083. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0407-2015·2014-12-10

    Customed Medical Kits Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 100 units of medical kits (Catalog # 900-913) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    , Catalog # 900-913 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states