Hazard

Needle Defect recalls

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

What the numbers show

Total: 13
Critical: 0
Severe: 1
Most recent: 2026-04-08

Of the 13 needle defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (8%) 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 needle defect 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.

1–13 of 13

HighFDA (Devices)·Z-1684-2026·2026-04-08
CPX 4 tall height tissue expander infusion needles may be blunt
Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the smooth tall height range because the infusion sets may contain a dull or blunt needle tip.
Product
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1687-2026·2026-04-08
Artoura ultra high profile expander infusion needles may be blunt
Mentor is recalling Artoura Breast Tissue Expanders in the smooth ultra high profile range because the infusion sets may contain a dull or blunt needle tip.
Product
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1686-2026·2026-04-08
Artoura breast tissue expander infusion set needles may be blunt
Mentor Texas is recalling Artoura Breast Tissue Expanders because the infusion sets may contain a dull or blunt needle tip that may be difficult to advance or may break.
Product
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1681-2026·2026-04-08
CPX 4 SILTEX low height expander infusion needles may be blunt
Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the SILTEX low height range because the infusion sets may contain a dull or blunt needle tip.
Product
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1682-2026·2026-04-08
CPX 4 low height tissue expander infusion needles may be blunt
Mentor is recalling the CPX 4 US Breast Tissue Expander with Suture Tabs, smooth low height 650 cc, because the infusion sets may contain a dull or blunt needle tip.
Product
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1683-2026·2026-04-08
CPX 4 medium height tissue expander infusion needles may be blunt
Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the smooth medium height range because the infusion sets may contain a dull or blunt needle tip.
Product
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1685-2026·2026-04-08
Artoura textured tissue expander infusion set needles may be blunt
Mentor is recalling textured Artoura Breast Tissue Expanders with integral injection dome because the infusion sets may contain a dull or blunt needle tip.
Product
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1481-2026·2026-03-11
B. Braun 21G 4.4 cm winged infusion needles may break
B. Braun Medical is recalling 21G x 4.4 cm Winged Infusion devices, model 7B3050, because the needle tip may be dull or blunt, difficult to advance, or may break.
Product
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percut
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1482-2026·2026-03-11
B. Braun 21GA winged infusion single packs may have blunt needles
B. Braun Medical is recalling 21GA Winged Infusion single packs, model 7A3842, because the needle tip may be dull or blunt, difficult to advance, or may break.
Product
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneou
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1483-2026·2026-03-11
B. Braun 21GA winged infusion sets may have blunt needle tips
B. Braun Medical is recalling 21GA Winged Infusion Sets, model 7M2802, because the needle tip may be dull or blunt, difficult to advance, or may break.
Product
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0534-2025·2024-12-04
Medline Shoulder Repair Pack-LF Recalled for Incorrect Surgical Components
Medline is recalling Shoulder Repair Pack-LF surgical kits (lot 24ABO552) due to incorrect needle type/size and suture diameter/length in some packages. No patient injuries have been reported.
Product
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2384-2021·2021-09-08
MY01 Continuous Compartmental Pressure Monitor Recalled for Out-of-Specification Needle
MY01, INC. is recalling the MY01 Continuous Compartmental Pressure Monitor (37 units) due to an incorrect needle with out-of-specification trocar geometry. The affected devices may require higher force to penetrate patient skin.
Product
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1112-2021·2021-02-24
Combat Medical Systems Recalls Low Titer Type O FWB Transfusion Sets
Combat Medical Systems, LLC is recalling 1021 units of Low Titer Type O FWB Transfusion Sets due to the potential for bent or disconnected needles in the components.
Product
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
Category
Medical Device
Distribution
Distributed nationwide