The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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.

426–450 of 2228

  • ModerateFDA (Devices)·Z-2129-2020·2020-06-03

    Teleflex Recalls Sprotte Lumbar Puncture Needles Due to Sterility Concerns

    Teleflex Medical is recalling 4,227 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing their sterility.

    Product
    Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2020·2020-05-27

    BD Posiflush SF Saline Flush Syringe Recalled for Packaging Holes

    Becton Dickinson is recalling BD Posiflush SF Saline Flush Syringes because holes in the packaging may compromise the sterile field.

    Product
    BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 110 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Defects

    Access Scientific LLC is recalling 1,864 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2020·2020-05-20

    DeRoyal Sterile Custom Kits Recalled Due to Packaging Holes

    DeRoyal Industries is recalling sterile custom kits packaged with BD PosiFlush syringes because holes in the packaging may compromise sterility.

    Product
    DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-6209.03 b. H* Vein Pack, 89-6209.04 c. PICC Line Tray Pgybk, 89-6150.12 d. Umbilical Arterial Cath, 89-9370.01 e. P
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1973-2020·2020-05-20

    Access Scientific Recalls BD PosiFlush Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 6,254 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contras
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 4,187 saline flush syringes used in vascular kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/10859821006473 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast med
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2020·2020-05-20

    Edwards Lifesciences Recalls Sterile Oxymetry Oligon Catheter Kits

    Edwards Lifesciences is recalling 597 sterile catheter kits because their packaging was compromised, potentially affecting sterility.

    Product
    Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1972-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Defects

    Access Scientific LLC is recalling 2,697 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast med
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2020·2020-05-20

    Access Scientific Recalls BD PosiFlush Saline Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 6,066 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 7,395 saline flush syringes used in POWERWAND kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast med
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1978-2020·2020-05-20

    Access Scientific Recalls BD PosiFlush Saline Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 30 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit. REF/UDI / 94114/10859821006220 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast med
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1979-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 570 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL catheters because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2020·2020-05-20

    Access Scientific Recalls Pediatric Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 120 units of BD PosiFlush SF Saline Flush Syringes used in pediatric kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 2,055 saline flush syringes because holes in the packaging compromised their sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / 94107/10859821006206 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2020·2020-05-20

    Access Scientific Recalls BD PosiFlush Saline Flush Syringes Due to Packaging Defects

    Access Scientific LLC is recalling 50 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1926-2020·2020-05-13

    Stryker Recalls Spy-Phi Drapes Packaged in Unsealed Pouches

    Stryker is recalling 21,078 units of Spy-Phi Drapes because they were packaged in unsealed pouches, compromising sterility.

    Product
    Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1925-2020·2020-05-13

    Stryker Recalls Spy-Phi Drapes Due to Unsealed Pouches

    Stryker is recalling 26,298 units of Spy-Phi Drapes and Packs because sterile drapes were packaged in unsealed pouches, compromising sterility.

    Product
    Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1689-2020·2020-04-15

    Bard Jamshidi Bone Marrow Biopsy Needle Recalled for Sterility Compromise

    Bard Peripheral Vascular Inc is recalling Jamshidi Bone Marrow Biopsy/Aspiration Needles because packaging pouches may not be sealed properly, compromising sterility.

    Product
    Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2020·2020-04-01

    Karl Storz Flexible Neuroscopes Recalled Due to Sterilization Manual Error

    Karl Storz is recalling 42 flexible neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.

    Product
    Karl Storz, Model # 11161C2, Flexible Neuroscope
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1505-2020·2020-03-25

    TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Sterility Concerns

    TeDan Surgical Innovations is recalling Quick Start Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing a risk of infection.

    Product
    DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1504-2020·2020-03-25

    TeDan 3COR Distraction Screws Recalled for Potential Sterility Compromise

    TeDan Surgical Innovations is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.

    Product
    D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by tra
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1483-2020·2020-03-25

    Teleflex Pilling Aortic Punch Recalled for Potential Sterile Packaging Compromise

    Deroyal Industries is recalling 669 units of Teleflex Pilling Aortic Punches because the sterile packaging may be compromised, potentially affecting cardiovascular surgical procedures.

    Product
    Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1447-2020·2020-03-11

    Recall of Force TriVerse Electrosurgical Kits Due to Sterility Concerns

    Covidien is recalling Force TriVerse Electrosurgical Kits distributed in EMEA due to potential sterile packaging compromise, which may increase infection risk.

    Product
    Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREA
    Category
    Medical Device
    Distribution
    Distributed nationwide