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.

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 2235

  • HighFDA (Devices)·Z-2387-2020·2020-06-24

    Stryker Gamma3 End Cap Recalled Due to Compromised Sterility

    Stryker GmbH is recalling specific Gamma3 End Caps because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2385-2020·2020-06-24

    Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity

    Stryker GmbH is recalling specific lots of locking screws because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2020·2020-06-24

    Stryker Locking Screw Recall Due to Potential Sterility Compromise

    Stryker is recalling specific locking screws because the packaging seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2381-2020·2020-06-24

    Stryker Locking Screw Recall Due to Potential Sterility Compromise

    Stryker GmbH is recalling specific lots of locking screws because blister pack seals may be compromised, potentially affecting sterility.

    Product
    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2369-2020·2020-06-24

    Resource Optimization Recalls Regard SRHS Central Line Kits Due to Packaging Defects

    Resource Optimization & Innovation LLC is recalling Regard SRHS Central Line Kits because holes in the packaging may compromise the sterile field.

    Product
    Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2174-2020·2020-06-10

    FDA Recalls Sterile Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile surgical packs because they were manufactured in a facility not registered by the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2130-2020·2020-06-03

    Teleflex Recalls Sprotte Lumbar Puncture Needles Due to Sterility Concerns

    Teleflex Medical is recalling 800 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing sterility.

    Product
    Sprotte Needle, REF 33115131B w/ Intro 20 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…
    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-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…
    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…
    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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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…
    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…
    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…
    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…
    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-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…
    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-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.…
    Category
    Medical Device
    Distribution
    8 states
  • 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