Hazard

Wrong Component recalls

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

What the numbers show

Total: 18
Critical: 0
Severe: 0
Most recent: 2026-06-10

Of the 18 wrong component 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 wrong component 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.

1–18 of 18

HighFDA (Devices)·Z-2262-2026·2026-06-10
Baxter Exacta Mix inlet sets may contain incorrect 0.8-micron filters
Exacta Mix Vented Micro-Volume Inlet tubing sets are being recalled because affected lots may contain 0.8-micron filters in place of the validated 3-micron filters.
Product
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1313-2026·2026-02-18
Adult intubation trays recalled over a smaller catheter packed inside
Medline is recalling 130 Adult Intubation Trays because an 8 Fr suction catheter may have been packed in place of the required 14 Fr catheter.
Product
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1312-2026·2026-02-18
Suction catheter kits recalled over a smaller catheter packed inside
Medline is recalling 141,971 of its 14 Fr Suction Catheter Kits because an 8 Fr catheter may have been packed in place of the required 14 Fr catheter.
Product
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1234-2026·2026-02-11
Acetabular liners recalled over packages containing the wrong component
Encore Medical is recalling 49 EMPOWR acetabular system liners after a package labeled 942-01-40G was found to contain a 942-01-36H liner.
Product
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1233-2026·2026-02-11
Knee tibial inserts recalled over a possible packaging discrepancy
Encore Medical is recalling 19 EMPOWR 3D Knee Tibial Inserts because several acetabular system and knee insert devices may have a packaging discrepancy.
Product
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0572-2026·2025-11-26
Nephrostomy balloon kits recalled after containing the wrong sized catheter
Olympus is recalling 60 Nephro-EZDilate nephrostomy balloon catheter kits because they contained a 4mm x 4cm urinary tract balloon instead of the correct 8mm x 15cm nephrostomy balloon.
Product
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0530-2025·2024-12-04
AMS Artificial Urinary Sphincter Control Pump: Mislabeled Packaging Recall
Boston Scientific recalled 16 units of AMS Artificial Urinary Sphincter Control Pumps due to mislabeled packaging where devices labeled as Pressure Regulating Balloons actually contained Control Pumps.
Product
AMS Artificial Urinary Sphincter Control Pump
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2244-2024·2024-07-10
MicroPort Knee Implant Recall: Wrong Size Component in Packaging
MicroPort's EVOLUTION MP knee implants recalled due to one confirmed case where a Size 3 left-side component was packaged in a Size 4 right-side box. No injuries reported; distribution is limited to China with no U.S. inventory.
Product
EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2002-2023·2023-07-05
Perifix Epidural Anesthesia Kits Recalled for Incorrect Filter Straw
B. Braun Medical recalled 16,070 Perifix epidural anesthesia kits that were assembled with an incorrect filter straw. The kits were distributed nationwide.
Product
Perifix¿ / Epidural anesthesia kit (10 count carton)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1674-2023·2023-06-07
LINK SymphoKnee System Femoral Augment Recalled for Incorrect Implant in Packaging
Linkbio Corp. is recalling 11 units of the LINK SymphoKnee System L-Shaped Femoral Augment because the packaging contains the opposite side of the implant. This error could result in implantation of the wrong component if not detected.
Product
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1418-2022·2022-07-27
Genesis II Tibial Baseplate Devices Recalled for Packaging Error
Smith & Nephew recalled 31 Genesis II Tibial Baseplate devices that were mispackaged with contents not matching the outer box label. This could result in implanting the wrong-sized component during knee surgery.
Product
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0899-2022·2022-04-20
iTotal Identity Knee Replacement System—incorrect tibial base plate packaged
Conformis is recalling specific units of the iTotal Identity Posterior Stabilised Knee Replacement System due to incorrect tibial base plate implants being packaged in surgical kits.
Product
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2746-2020·2020-08-12
Smith & Nephew Recalls SUTUREFIX ULTRA Suture Due to Packaging Error
Smith & Nephew is recalling 868 units of SUTUREFIX ULTRA Suture because a packaging error caused an XL drill to be included instead of the correct S drill.
Product
SUTUREFIX ULTRA Suture, Product number 72203855
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-1794-2020·2020-04-29
Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak Recall
Alcon Research LLC is recalling 102 sterile procedure packs due to a potential mix-up with a 25-gauge infusion cannula.
Product
Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0007-2018·2017-10-11
Implant Direct Recalls Swish Duo-Grip Healing Collars Due to Wrong Component
Implant Direct is recalling 50 units of Swish Duo-Grip Healing Collars because the packages contained the wrong component size.
Product
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0627-2017·2016-11-30
DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws
DePuy Spine is recalling SKYLINE Variable Self-Tapping Screws because the packaging may contain Constrained Ti screws instead.
Product
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic ori
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1947-2014·2014-07-09
Alcon Anterior Chamber Cannula Recall Due to Incorrect Component
Alcon is recalling CUSTOM-PAKs that contain a sharp tip needle instead of the intended anterior chamber cannula.
Product
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1610-2014·2014-05-21
Ortho Development Recalls PS-C Femoral Knee Implant Components
Ortho Development Corporation is recalling five PS-C Femoral Nonporous Rt Sz 6 knee implant components because pegged versions were found in boxes labeled for the pegless version.
Product
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Category
Medical Device
Distribution
Distributed nationwide