Hazard

Component Defect recalls

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

What the numbers show

Total: 126
Critical: 0
Severe: 14
Most recent: 2026-06-24

Of the 126 component 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 14 (11%) 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 component 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.

51–75 of 126

ModerateFDA (Devices)·Z-0121-2026·2025-10-15
Continuous epidural anesthesia sets recalled over catheter connector lid position
B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Sets, product code CE17TFC, because the lid of the catheter connector may be in the incorrect position.
Product
PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound Epidural Catheter - 19 Ga. Closed tip. Product Code: CE17TFC. Product Description: CE17TFC CONTINUOUS EPID SET W/17G TUOHY.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0120-2026·2025-10-15
Open tip epidural trays recalled over catheter connector lid position
B. Braun is recalling 2,760 PERIFIX FX Continuous Epidural Anesthesia Trays, product code CE17TKFS, because the lid of the catheter connector may be in the incorrect position.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0118-2026·2025-10-15
Fixed wing epidural trays recalled over catheter connector lid position
B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Trays, product code CE17TKFSDT, because the lid of the catheter connector may be in the incorrect position.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0114-2026·2025-10-15
Epidural basic trays recalled over catheter connector lid position defect
B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Trays, product code CE17TBFC, because the lid of the catheter connector may be in the incorrect position.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0115-2026·2025-10-15
Epidural fixed trays recalled over catheter connector lid position defect
B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Trays, product code CE17TKFCPS, because the lid of the catheter connector may be in the incorrect position.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCPS. Product Description: CE17TKFCPS EPIDURAL FULL TRAY.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0125-2026·2025-10-15
Combined spinal epidural trays recalled over catheter connector lid position issue
B. Braun is recalling 60 Combined Spinal and Epidural Anesthesia Tray 2 units because the lid of the catheter connector may be in the incorrect position.
Product
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: SESK. Product Description: SESK COMBINED SPINAL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0126-2026·2025-10-15
Custom epidural anesthesia trays recalled over catheter connector lid position
B. Braun is recalling 5,770 Design Options PERIFIX FX Epidural Anesthesia Trays because the lid of the catheter connector may be in the incorrect position.
Product
Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 20071769. 3. CESK FLETCHER ALLEN HOSPITAL. 4. CESK WASHOE MEDICAL CENTER. 5. CESK DETROIT MEDI
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0124-2026·2025-10-15
Pain management trays recalled over catheter connector lid position defect
B. Braun is recalling 2,450 Design Options Pain Management Trays because the lid of the catheter connector may be in the incorrect position.
Product
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONI
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0123-2026·2025-10-15
Open tip spinal epidural trays recalled over catheter connector lid position
B. Braun is recalling 2,840 Combined Spinal and Epidural Anesthesia Trays, product code NES1727KFX, because the lid of the catheter connector may be in the incorrect position.
Product
Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle and 19 Ga. Open Tip PERIFIX FX Springwound Epidural Catheter. Product Code: NES1727KFX. Product Description: NES1727KFX W /17GA T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2553-2025·2025-09-17
Hemostasis valves recalled because deformed quad rings may shed foreign bodies
10Fore Hemostasis Valves are recalled because of a manufacturing issue where the silicone quad ring is deformed or damaged and may cause a foreign body in the fluid pathway. 447 units are affected.
Product
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional d
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2174-2025·2025-08-06
HeartSine samaritan public access defibrillators may not deliver shocks properly
HeartSine SAM 350P, 360P and 450P public access defibrillators are being recalled because a component manufacturing issue means the device may not function properly to deliver shocks. 190,516 units affected.
Product
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1458-2025·2025-04-16
Medline Heart Basin Procedure Kits with Aortic Cannula Recalled
Medline medical procedure kits containing Medtronic Aortic Root Cannula are recalled due to potential excess material in the male luer connectors on the aortic cannula.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1009-2025·2025-01-29
Baxter Solution Set with Duo-Vent Spike Recalled for Inverted Clamps
Baxter Healthcare is recalling specific lots of its Solution Set with Duo-Vent Spike due to inverted side clamps that may render the tubing unusable. The affected product was distributed nationwide.
Product
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0628-2025·2024-12-11
MEDLINE dental and oral surgery kits recalled due to defective component
MEDLINE is recalling four types of dental and oral surgery convenience kits that were manufactured using SafeAir Smoke Evacuation Pencils, which were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0640-2025·2024-12-11
MEDLINE convenience kits recalled due to defective component
Medline is recalling multiple lots of its convenience kits because they contain a component (SafeAir Smoke Evacuation Pencil) that was previously recalled by Stryker. The affected kits are distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0639-2025·2024-12-11
Medline Convenience Kits Recalled Due to Defective Smoke Evacuation Component
Medline is recalling L&D convenience kits distributed nationwide because they were manufactured with smoke evacuation pencils that Stryker subsequently recalled. The affected kits contain components from lot 23HMI048.
Product
MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0629-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Pencil Component
MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.
Product
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0622-2025·2024-12-11
Medline Tracheostomy Convenience Kits Recalled Due to Defective Component
Medline is recalling 88 units of tracheostomy convenience kits containing a defective smoke evacuation pencil component that was previously recalled by Stryker. Products were distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0648-2025·2024-12-11
Medline Recalls Convenience Kits with Recalled SafeAir Smoke Evacuation Pencil
Medline is recalling 1,921 medical convenience kits distributed nationwide that contain SafeAir Smoke Evacuation Pencil components previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC BRE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0625-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Component
Medline Industries is recalling 30,092 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4) HEART CDS, REF CDS840387T; 5) OPEN HEART CDS PART A, REF CDS840402AF; 6) OPEN HEART CDS PART A, REF CDS840402AI; 7) HEART PACK,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0633-2025·2024-12-11
MEDLINE Recalls Medical Convenience Kits Containing Recalled SafeAir Component
MEDLINE is recalling approximately 25,877 medical convenience kits distributed nationwide that contain SafeAir Smoke Evacuation Pencil components previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTICS FREE FLAP, REF CDS983493M; 4) PLASTIC TORSO-LF, REF CDS983496L; 5) PLASTIC TORSO-LF, REF CDS983496M; 6) PLASTIC HEAD AND NECK-LF, REF CDS983498N; 7) ACH
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0624-2025·2024-12-11
Medline Surgical Kits Recalled for SafeAir Smoke Evacuation Pencils
Medline is recalling 1,271 surgical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. The affected kits were distributed nationwide, and healthcare facilities should discontinue use.
Product
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST CHARLES PORT, REFDYNJ909591
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0636-2025·2024-12-11
Medline Colon Wound Closure Packs recalled due to defective component
Medline is recalling Colon Wound Closure Packs (REF DYNJ52141B) because they were manufactured using SafeAir Smoke Evacuation Pencils that were recalled by Stryker. The kits have been distributed nationwide.
Product
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0641-2025·2024-12-11
Medline Surgical Convenience Kits Recalled for Defective Component
Medline is recalling multiple surgical convenience kits because they contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker. The recall affects 1,952 units distributed nationwide; no injuries have been reported.
Product
MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ0826768P; 4) VAGINAL PACK, REF DYNJ59081C; 5)VAGINOPLASTY PACK, REF DYNJ65807C; 6) ACH MAJOR VAGINAL PACK, REF DYNJ67757B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0637-2025·2024-12-11
MEDLINE Burn Convenience Kits Recalled Due to Defective Component
MEDLINE is recalling 486 burn convenience kits because they were manufactured using SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
Category
Medical Device
Distribution
Distributed nationwide