Hazard

Cytotoxicity recalls

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

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2026-07-01

Of the 9 cytotoxicity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 cytotoxicity 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.

1–9 of 9

ModerateFDA (Devices)·Z-2526-2026·2026-07-01
Multi-Snare Set catheter fails biocompatibility requirements
PFM Medical Inc. is recalling Multi-Snare Set catheters (5 mm and 10 mm sizes) because they failed biocompatibility testing for in-vitro cytotoxicity and could cause localized inflammation and tissue irritation if they contact a patient's blood vessels.
Product
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2331-2025·2025-08-27
Bayonet injection needles recalled after showing elevated cytotoxicity in testing
Bayonet Luer-Lock injection needles, models 50-353-23 and 50-345-23, are recalled because affected product showed elevated cytotoxicity values, which may present a risk of intolerance or allergic reaction.
Product
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1307-2022·2022-07-06
Yukon Straight Rod spinal implants recalled for discoloration and contamination
K2M Inc. is recalling certain Yukon Straight Rod spinal implants due to discoloration from trace amounts of inorganic phosphorous compound. The contaminated devices may cause mild irritation or adverse tissue reactions.
Product
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2119-2017·2017-05-31
EBI Patient Care Recalls SpF-PLUS Implantable Stimulators Due to Cytotoxicity
EBI Patient Care, Inc. is recalling 33 SpF-PLUS Implantable Stimulators due to higher than allowed cytotoxicity levels found during routine process monitoring.
Product
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2118-2017·2017-05-31
EBI Patient Care Recalls Spinal Fusion Stimulators Due to Cytotoxicity
EBI Patient Care is recalling 33 SpF-XL IIB implantable stimulators because routine monitoring found higher than allowed cytotoxicity levels.
Product
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1912-2016·2016-06-15
DePuy Synthes Flexible Shaft Reamers Recalled for Cytotoxicity Failure
Synthes (USA) Products LLC is recalling 244 DePuy Synthes 8.0 mm Flexible Shaft Reamers because they failed biological safety evaluations for cytotoxicity.
Product
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0788-2016·2016-02-17
Zimmer Biomet Recalls Endobon Xenograft Granules Due to Cytotoxicity Failure
Biomet France SARL is recalling Endobon-Xenograft Granules because the product failed cytotoxicity tests at 36 months. Use past the 18-month shelf life may cause patient illness or injury.
Product
Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: " Alveolar ridge augmentation/recons
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-1699-2015·2015-06-17
Zimmer Recalls M/L Taper Hip Stems Due to Cytotoxicity Levels
Zimmer is voluntarily recalling 752 M/L Taper hip implants because they contain higher than allowed cytotoxicity levels, posing a risk of adverse biological response.
Product
M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, pol
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2265-2014·2014-08-27
Synthes 3.0 MM TI Cannulated Screw Set Recalled for Cytotoxicity Risk
Synthes, Inc. is recalling 3.0 MM TI Cannulated Screw Instrument and Implant Sets that were exposed to flood water and reprocessed. Testing indicated the components may be cytotoxic.
Product
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Category
Medical Device
Distribution
2 states