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.

Which agencies issued them

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.

1226–1250 of 2235

SevereFDA (Devices)·Z-0889-2017·2016-12-28
Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise
Medtronic is recalling 1,293,169 Clearify Visualization Systems because a breach of the sterile barrier compromises product sterility.
Product
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0890-2017·2016-12-28
Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise
Medtronic is recalling 230 Clearify Visualization Systems because the sterile barrier was breached, compromising product sterility. The recall covers worldwide distribution.
Product
Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0852-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 50 units of Low Profile Abutments because some pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0880-2017·2016-12-28
Stryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
Stryker Howmedica Osteonics Corp. is recalling specific lots of GAM Kirschner Wires and T2 K-Wires because a manufacturing error may have compromised the sterile pouch seal.
Product
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0836-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 101 units of a specific dental implant abutment because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0821-2017·2016-12-28
Stanmore Implants Recalls Tibial Components Due to Packaging Puncture
Stanmore Implants Worldwide Ltd. is recalling 51 tibial components because the device stem may have punctured the sterile packaging.
Product
Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0752-2017·2016-12-21
Integra York Metzenbaum Scissors Recalled Due to Packaging Seal Separation
Integra York PA, Inc. is recalling 50 units of sterile Metzenbaum Scissors because packaging seals may separate, compromising sterility.
Product
Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0751-2017·2016-12-21
Integra York Recalls Sterile Rochester-Pean Hemostatic Forceps Due to Seal Defect
Integra York PA, Inc. is recalling 150 units of sterile Rochester-Pean Hemostatic Forceps because packaging seals may separate, compromising sterility.
Product
Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0735-2017·2016-12-21
C.R. Bard Recalls 70cc Irrigation Syringes Due to Package Defect
C.R. Bard is recalling 452,728 units of 70cc irrigation syringes because a package defect may compromise product sterility.
Product
BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0736-2017·2016-12-21
C.R. Bard Recalls 70cc Piston Syringes Due to Package Defect
C.R. Bard is recalling 70cc Piston Syringes because a package slit defect may compromise product sterility.
Product
BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0756-2017·2016-12-21
Recall of Sterile Specimen Containers Due to Packaging Defect
Covidien LLC is recalling 5,187,100 sterile specimen containers because a packaging defect compromised the sterility of the outer surface.
Product
Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0737-2017·2016-12-21
C.R. Bard Recalls Piston Syringes Due to Package Defect Risk
C.R. Bard is recalling specific lots of 60cc Piston Syringes because a package slit defect may compromise product sterility.
Product
BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0738-2017·2016-12-21
C.R. Bard Recalls BARDIA 60cc Piston Irrigation Syringes Due to Package Defect
C.R. Bard is recalling BARDIA 60cc Piston Irrigation Syringes because a slit defect in the packaging may compromise product sterility.
Product
BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0698-2017·2016-12-14
Elana Surgical KitHUD Recalled Due to Compromised Sterile Packaging Integrity
Elana, Inc. is voluntarily removing four Elana Surgical KitHUD units because the sterile packaging of the included catheter may be compromised.
Product
Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0663-2017·2016-12-07
Spectranetics Recalls Medical Devices Due to Compromised Sterile Packaging
Spectranetics is voluntarily recalling the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon because their outer sterile packaging may be compromised.
Product
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0675-2017·2016-12-07
Teleflex Recalls Arrow OnControl Bone Marrow Biopsy System Trays
Teleflex Medical is recalling 113,647 units of Arrow OnControl Bone Marrow Biopsy System Trays due to a potential incomplete seal on the outer sterile package.
Product
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0635-2017·2016-11-30
Merit Medical Procedure Kits Recalled for Compromised Sterile Barrier
Merit Medical Systems is recalling 53 Procedure Kits due to a compromised sterile barrier. The kits were distributed nationwide to specific states and Japan.
Product
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0655-2017·2016-11-30
Hologic Recalls SURESOUND22 Uterine Sounds Due to Sterile Barrier Breach
Hologic is recalling SURESOUND22 uterine sound multipacks because a breach in the sterile barrier compromises product sterility.
Product
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0632-2017·2016-11-30
Merit Medical Recalls Manifold Kits Due to Compromised Sterile Barrier
Merit Medical Systems is recalling 40 Manifold Kits (Catalog No. K09-11867AP) because the sterile barrier is compromised, posing a risk of infection.
Product
Manifold Kit. Catalog Number K09-11867AP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0634-2017·2016-11-30
Merit Medical Recalls Pressure Monitoring Kits Due to Sterile Barrier Compromise
Merit Medical Systems is voluntarily recalling 130 MeriTrans Pressure Monitoring Kits because a compromised sterile barrier may affect product sterility.
Product
Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0633-2017·2016-11-30
Merit Medical Procedure Kits Recalled for Compromised Sterile Barrier
Merit Medical Systems is voluntarily recalling specific Procedure Kits due to a compromised sterile barrier, which may affect the sterility of the contents.
Product
Waste Management Kit. Catalog Number K10-04381AP
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0642-2017·2016-11-30
Synthes Extraction Hook Recall Due to Peel Pouch Delamination
Synthes (USA) Products LLC is recalling 114 sterile extraction hooks because their peel pouches are delaminating, potentially compromising sterility.
Product
Extraction Hook - Sterile for TI Cannulated Nails
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0643-2017·2016-11-30
Synthes Recalls 2.5 mm Calibrated Reaming Rods Due to Pouch Delamination
Synthes (USA) Products LLC is recalling 260 sterile 2.5 mm TI Calibrated Reaming Rods because their peel pouches are delaminating.
Product
2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0641-2017·2016-11-30
Synthes Recalls 2.5 mm Guide Rods Due to Peel Pouch Delamination
Synthes (USA) Products LLC is recalling 139 units of 2.5 mm Guide Rods because their sterile peel pouches are delaminating.
Product
2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0141-2017·2016-11-23
Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns
Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection vials because an FDA inspection raised concerns that the product's sterility may be compromised.
Product
L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
Category
Drug
Distribution
Distributed nationwide