Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,228
Critical: 3
Severe: 255
Most recent: 2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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 2228

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
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 adapt
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-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 include
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¿ Syr
Category
Medical Device
Distribution
Distributed nationwide
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-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 base
Category
Medical Device
Distribution
1 state
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 B
Category
Medical Device
Distribution
Distributed nationwide
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
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-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
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
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-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
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
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
SevereFDA (Drugs)·D-0140-2017·2016-11-23
Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns
Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection because an FDA inspection raised concerns that the product's sterility may be compromised.
Product
L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0253-2017·2016-10-26
Windstone Medical Recalls Ortho Kits Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 145 Ortho Kits because the disposable gloves included may contain splits or holes that compromise sterility.
Product
Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0185-2017·2016-10-26
Windstone Medical Packaging Recalls Extremity Tray Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 816 Extremity Tray kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0141-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Product
Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0180-2017·2016-10-26
Windstone Medical Packaging Recalls Endoscopy Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 304 Endoscopy Packs because disposable gloves in the kits may have splits or holes that compromise sterility.
Product
Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0260-2017·2016-10-26
Windstone Medical Packaging Recalls Peri Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 115 Peri Kits (PSS1037) because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0231-2017·2016-10-26
Windstone Medical Recalls Major General Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 852 Major General Packs because Medtronic gloves inside may have splits or holes that compromise sterility.
Product
Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide